1. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patient in its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the signs and symptoms of dry eye disease.

    "We are excited to have recently begun dosing patients in the Phase 2 clinical trial of OTX-DED," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer. "Many dry eye patients experience episodic flares of their signs and symptoms related primarily to inflammation. Topical steroids are commonly used for…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patient in its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the signs and symptoms of dry eye disease.

    "We are excited to have recently begun dosing patients in the Phase 2 clinical trial of OTX-DED," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer. "Many dry eye patients experience episodic flares of their signs and symptoms related primarily to inflammation. Topical steroids are commonly used for the short-term treatment of dry eye but all of them contain preservatives that can lead to ocular surface toxicities such as itching and stinging and, when used more chronically, other adverse events such as elevated intraocular pressure or cataracts. OTX-DED is a new, investigational, physician-administered, preservative-free intracanalicular insert designed to deliver either 0.2 or 0.3 mg doses of dexamethasone that has the potential to provide effective treatment with fewer of those toxicities and adverse events. Along with OTX-CSI, our cyclosporin-containing intracanalicular insert, we now have two potentially transformative dry eye product candidates in Phase 2 development, one to chronically treat dry eye disease (OTX-CSI) and the other to acutely treat dry eye disease (OTX-DED), thereby effectively covering the broad spectrum of the approximately $5 billion global dry eye disease market."

    The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different-strength formulations of OTX-DED (dexamethasone intracanalicular ophthalmic insert) in a total of approximately 150 subjects with dry eye disease. This trial is designed to assess the safety and efficacy of these two formulations of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, corneal fluorescein staining eye dryness symptoms using visual analog scale (VAS), and other secondary endpoints in comparison with a matched vehicle control hydrogel insert.

    About Dry Eye Disease

    Dry eye disease is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production.

    The global market for dry ocular surface disease, which we refer to as dry eye disease, was estimated by Market Scope at $5.1 billion in 2019 with the U.S. market representing $2.1 billion.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix is currently evaluating each of OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease in Phase 2 clinical trials. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; potential market sizes for indications targeted by the Company's product candidates, if approved; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  2. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report fourth quarter and year end financial results on Thursday, March 11, 2021. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 4:30 p.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report fourth quarter and year end financial results on Thursday, March 11, 2021. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 4:30 p.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 7189257. An archive of the webcast will be available until June 10, 2021 on the Company's website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant is an FDA approved device to prevent wound leaks in corneal incisions following cataract surgery.

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  3. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will participate at the following conferences:

    Cowen 41st Annual Health Care Conference
    Date: Monday, March 1, 2021
    Analyst-hosted fireside chat: 12:30 PM ET

    Raymond James 42nd Annual Institutional Investors Conference
    Date: Wednesday, March 3, 2021
    Analyst-hosted fireside chat: 9:10 AM ET

    H.C. Wainwright Global Life Sciences Conference
    Date: March 9-10, 2021
    Pre-Recorded Formal Presentation will be made available on Tuesday, March 9, 2021 at 7:00 AM ET

    Management will be available throughout the day for virtual investor meetings…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will participate at the following conferences:

    Cowen 41st Annual Health Care Conference

    Date: Monday, March 1, 2021

    Analyst-hosted fireside chat: 12:30 PM ET

    Raymond James 42nd Annual Institutional Investors Conference

    Date: Wednesday, March 3, 2021

    Analyst-hosted fireside chat: 9:10 AM ET

    H.C. Wainwright Global Life Sciences Conference

    Date: March 9-10, 2021

    Pre-Recorded Formal Presentation will be made available on Tuesday, March 9, 2021 at 7:00 AM ET

    Management will be available throughout the day for virtual investor meetings at all of the conferences. If you plan to attend at least one of the conferences and are interested in meeting with management, please contact your Cowen, Raymond James or H.C. Wainwright representative.

    A live webcast of the fireside chats during the Cowen 41st Annual Health Care Conference and the Raymond James 42nd Annual Institutional Investors Conference, along with a replay of the pre-recorded presentation during the H.C. Wainwright Global Life Sciences Conference, can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant is an FDA approved device to prevent wound leaks in corneal incisions following cataract surgery.

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  4. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced its intention to present data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant for the treatment of patients with wet age-related macular degeneration (wet AMD) and other retinal diseases, at the upcoming Angiogenesis, Exudations, and Degeneration 2021 Meeting being held virtually on February 12-13th.

    Details of Ocular's Presentation are as follows:

    TITLE: Intravitreal Hydrogel-Based Axitinib Implant (OTX-TKI) for the Treatment of Neovascular AMD: Phase 1 Trial Update
    PRESENTER: Andrew A. Moshfeghi, MD, MBA…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced its intention to present data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant for the treatment of patients with wet age-related macular degeneration (wet AMD) and other retinal diseases, at the upcoming Angiogenesis, Exudations, and Degeneration 2021 Meeting being held virtually on February 12-13th.

    Details of Ocular's Presentation are as follows:

    TITLE: Intravitreal Hydrogel-Based Axitinib Implant (OTX-TKI) for the Treatment of Neovascular AMD: Phase 1 Trial Update

    PRESENTER: Andrew A. Moshfeghi, MD, MBA, Associate Professor of Clinical Ophthalmology; Medical Director of the USC Roski Eye Institute; Director of Clinical Trials; Director of the Vitreoretinal Surgery Fellowship Program; and Director of the Medical Retina Fellowship Program

    PRESENTATION DATE AND TIME: Saturday, February 13, 2021, 12:30 p.m. ET

    "We are pleased to be presenting an update on OTX-TKI at the upcoming Angiogenesis meeting," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "OTX-TKI is an intravitral implant of axitinib delivered via injection, leveraging a new administration and mechanism of action for the treatment of patients with wet AMD and other retinal diseases. We are particularly encouraged with the interim data presented to date from the Phase 1 trial. The data support the product's safety profile and signal its potential biological activity and durability in patients with wet AMD across the first two dose cohorts and a portion of the third dose cohort for up to six months or longer in some cases."

    The presentation can be accessed February 13th on the "Events and Presentations" section of the Ocular Therapeutix website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including its presentation at future scientific or medical conferences; the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  5. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has granted (i) a non-statutory stock option to purchase up to an aggregate of 100,000 shares of common stock of Ocular Therapeutix subject to time-based vesting (the "Time-Based Option") and (ii) a non-statutory stock option to purchase up to an aggregate of 50,000 shares of common stock of Ocular Therapeutix subject to performance-based vesting (the "Performance-Based Option") to a new employee, Rabia Gurses Ozden, MD, as an inducement to her commencement of employment with Ocular. The award was made outside Ocular's 2014 Stock…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has granted (i) a non-statutory stock option to purchase up to an aggregate of 100,000 shares of common stock of Ocular Therapeutix subject to time-based vesting (the "Time-Based Option") and (ii) a non-statutory stock option to purchase up to an aggregate of 50,000 shares of common stock of Ocular Therapeutix subject to performance-based vesting (the "Performance-Based Option") to a new employee, Rabia Gurses Ozden, MD, as an inducement to her commencement of employment with Ocular. The award was made outside Ocular's 2014 Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock options were granted effective as of February 1, 2021, and each has an exercise price of $18.70 per share, the closing price of Ocular's common stock on February 1, 2021. The Time-Based Option has a ten-year term and is scheduled to vest over four years, with 25% of the original number of shares vesting on the one-year anniversary of Dr. Ozden's employment commencement date and the remainder vesting in equal monthly installments over the three years thereafter, subject to Dr. Ozden's continued service to Ocular through the applicable vesting dates. The Performance-Based Option vests and becomes exercisable in whole or in part if the Company achieves specified milestones, subject to Dr. Ozden's continued service to Ocular through the applicable vesting dates. The grant was approved by a majority of Ocular's independent directors at the recommendation of the Compensation Committee and was made as an inducement material to her acceptance of employment with Ocular in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options are subject to the terms and conditions of stock option agreements covering the grant and Ocular's 2019 Inducement Stock Incentive Plan, as amended to date.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  6. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced plans to present data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension at the Glaucoma 360 New Horizons Forum being held virtually on January 30th. As part of the event, Michael Goldstein, M.D., M.B.A., President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, has narrated a presentation on the OTX-TIC Phase 1 study that is available today and can be accessed on the "Events and Presentations" section of the Ocular Therapeutix website…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced plans to present data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension at the Glaucoma 360 New Horizons Forum being held virtually on January 30th. As part of the event, Michael Goldstein, M.D., M.B.A., President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, has narrated a presentation on the OTX-TIC Phase 1 study that is available today and can be accessed on the "Events and Presentations" section of the Ocular Therapeutix website.

    The Phase 1, prospective, multi-center, open-label, clinical trial is intended to evaluate safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. Interim data presented at Glaucoma 360 are from the four fully enrolled cohorts (cohort 1=5 subjects, cohort 2=4 subjects, cohort 3=5 subjects, and cohort 4=5 subjects). Formulations of cohort 3 and 4 hydrogel implant include composition for faster dissolution when compared with cohorts 1 and 2.

    In this Phase 1 clinical trial, all cohorts experienced a mean reduction in IOP from baseline of 7-11 mm Hg with onset of action as early as two days after insertion. Many subjects across the four cohorts demonstrated durability of activity of 6 months or longer with a single implant. Overall, no serious ocular adverse events were noted. The hydrogel drug delivery system consistently biodegraded in 5-7 months in cohorts 1 and 2 and in 3-5 months in cohorts 3 and 4. No meaningful changes in endothelial cell counts or pachymetry were observed across the cohorts. Evaluation remains ongoing for cohort 4. As is typical for early stage clinical trials, this trial is not powered to measure efficacy endpoints with statistical significance.

    "Compliance with topical drop therapy remains a clinical problem in the treatment of glaucoma and represents a large unmet medical need. OTX-TIC was developed to deliver travoprost for an extended duration of time and, if shown to be safe and effective, represents a possible solution to this problem. Continued long-term evaluation is ongoing but we are very excited by what we have seen with the early results from this trial," commented Dr. Goldstein. "We continue to believe that OTX-TIC has the potential for a unique and differentiated drug product profile. Based on these data we continue to plan to initiate a Phase 2 clinical trial in mid-2021."

    About OTX-TIC

    OTX-TIC is designed to be a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye and is intended for patients with glaucoma or ocular hypertension with a target duration of drug delivery of four months or longer. OTX-TIC is designed to directly address compliance issues by delivering travoprost over the course of several months with a single implant.

    About Glaucoma

    Glaucoma is a progressive and highly individualized disease in which elevated levels of IOP are associated with damage to the optic nerve, which results in irreversible vision loss. According to the World Health Organization, glaucoma is the second leading cause of blindness in the world. The Glaucoma Research Foundation estimates that over three million Americans have glaucoma.

    To lower IOP, physicians typically initiate treatment by prescribing drugs administered as eye drops. These drugs either decrease fluid production or enhance fluid drainage. The classes of topical drugs used to treat glaucoma include prostaglandin analogs, or PGAs, beta-blockers, alpha-adrenergic agonists and carbonic anhydrase inhibitors. PGAs are the most widely prescribed class of drugs for glaucoma and are considered first-line glaucoma treatment. PGAs reduce IOP by enhancing the clearance and drainage of ocular fluid. The most frequently prescribed PGA is once-daily latanoprost, although travoprost, unoprostone and bimatoprost are also frequently used in the management of open-angle glaucoma. In cases where glaucoma is not easily managed by a drug regimen, surgical or laser treatments may be undertaken.

    According to IMS Health data, approximately 35.6 million prescriptions were filled in the United States in 2019 for drugs administered by eye drops for the treatment of glaucoma, resulting in sales of approximately $3.3 billion. A typical prescription provides approximately one month of treatment. We expect prescription volume to grow, in large part as a result of the aging population. According to IMS Health, PGAs accounted for approximately half of the prescription volume in the glaucoma market in 2019.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including its presentation at future scientific or medical conferences; the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  7. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the promotion of Michael Goldstein, MD, MBA, to the newly created position of President, Ophthalmology. Dr. Goldstein will continue to report to Antony Mattessich, Ocular's President and Chief Executive Officer. With this promotion, Dr. Goldstein will be responsible for clinical operations and in that capacity will maintain his role as Chief Medical Officer. He will also be responsible for commercial operations in alignment with the overall Company strategy. The Company also announced the appointment of Rabia Gurses Ozden, MD, as Senior…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the promotion of Michael Goldstein, MD, MBA, to the newly created position of President, Ophthalmology. Dr. Goldstein will continue to report to Antony Mattessich, Ocular's President and Chief Executive Officer. With this promotion, Dr. Goldstein will be responsible for clinical operations and in that capacity will maintain his role as Chief Medical Officer. He will also be responsible for commercial operations in alignment with the overall Company strategy. The Company also announced the appointment of Rabia Gurses Ozden, MD, as Senior Vice President (SVP), Clinical Development. As SVP, Clinical Development, Dr. Ozden is responsible for leading the clinical development of Ocular Therapeutix's current and growing pipeline of indications focusing on the front and back of the eye. The strategic appointments are expected to play a key role in supporting Ocular's future growth and reflect Ocular's commitment to developing innovative therapies for diseases and conditions of the eye.

    "2020 has been a year of exciting growth for Ocular Therapeutix with the commercial success of DEXTENZA and with the development of our leading ophthalmology pipeline," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Recognizing the great opportunity to build upon our progress, I am thrilled to be expanding the organization with the promotion of Mike and with the addition of Rabia to our clinical team. Mike has played a key role in our recent successes, and I believe his strong leadership will continue to drive further success and future growth."

    "I am really excited about the work Ocular Therapeutix is doing in ophthalmology and our potential. We aim to keep developing exciting products to fulfill unmet needs in ophthalmology to benefit patients and to continue developing a best-in-class commercial team to deliver those products to market," said Michael Goldstein, Chief Medical Officer and President, Ophthalmology. "I would also like to welcome Rabia to the Ocular team. We are fortunate to attract a talent like Rabia who brings to Ocular a proven track record and broad therapeutic expertise in ophthalmology with subspecialty training in glaucoma."

    Dr. Ozden has over 15 years of experience in clinical development, clinical operations, and pharmacovigilance in pharmaceutical and medical device programs. Dr. Ozden has had numerous interactions with regulatory agencies for clinical support in product filings, clinical endpoint developments and label negotiation. Prior to joining Ocular, Dr. Ozden most recently served as the Chief Development Officer at Akouos, Inc. Previously, Dr. Ozden served as Chief Medical Officer of Nightstar Therapeutics plc, a gene therapy company focused on rare inherited retinal diseases, which was acquired by Biogen. She has held leadership positions at Applied Genetic Technologies Corporation and GlaxoSmithKline, and earlier in her career held clinical development and operations roles at Quark Pharmaceuticals, Bausch & Lomb Pharmaceuticals and Carl Zeiss Meditec AG. Dr. Ozden received her M.D. from Hacettepe University School of Medicine, completed her ophthalmology residency at Ankara University School of Medicine, and her clinical fellowship in Glaucoma at the New York Eye and Ear Infirmary.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  8. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the underwriters of its public offering that closed on December 18, 2020, have exercised in full their option to purchase an additional 558,750 shares of its common stock at the public offering price of $21.50 per share, less underwriting discounts and commissions. After giving effect to the option closing, the total number of shares of common stock sold by the Company in its public offering increased to 4,283,750 shares, which resulted in aggregate gross proceeds of approximately $92.1 million and aggregate net proceeds of approximately…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the underwriters of its public offering that closed on December 18, 2020, have exercised in full their option to purchase an additional 558,750 shares of its common stock at the public offering price of $21.50 per share, less underwriting discounts and commissions. After giving effect to the option closing, the total number of shares of common stock sold by the Company in its public offering increased to 4,283,750 shares, which resulted in aggregate gross proceeds of approximately $92.1 million and aggregate net proceeds of approximately $86.1 million after deducting underwriting discounts and commissions and estimated offering expenses.

    Jefferies LLC and Piper Sandler & Co. acted as joint book-running managers for the offering. Raymond James & Associates, Inc. and JMP Securities LLC acted as co-managers for the offering.

    The offering was made pursuant to a shelf registration statement on Form S-3 that became effective upon filing with the Securities and Exchange Commission (SEC). The offering was made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Electronic copies of the final prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

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  9. PDUFA Target Action Date Anticipated for October 2021

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

    "We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the…

    PDUFA Target Action Date Anticipated for October 2021

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

    "We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the sNDA would reflect the second expansion of the DEXTENZA label and would include the first indication for DEXTENZA treated primarily in the ophthalmology office setting," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "It is estimated that up to 10 million1,2,3 people in the U.S. annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete and significant potential market for DEXTENZA beyond its current use in the surgical setting. From a business perspective, ocular itching associated with allergic conjunctivitis is our first potential indication in the treatment of an ocular surface disease, paving the way for our two Phase 2 clinical programs in the treatment of dry-eye disease."

    The efficacy of DEXTENZA for the treatment of ocular itching was evaluated in four vehicle-controlled clinical trials for subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens (n=323). The sNDA offers data that Ocular believes supports that DEXTENZA demonstrated superiority to placebo vehicle for the treatment of ocular itching due to allergic conjunctivitis as evidenced by statistically significant differences in a pooled analysis of three well controlled Phase 3 clinical trials as well as in the Phase 2 clinical trial. At the primary endpoint for the pooled analysis of the three Phase 3 clinical trials (Day 8), ocular itching scores favored DEXTENZA treated subjects compared with placebo vehicle treated subjects at all three timepoints: 3 min (1.85 vs 2.55, p value = <0.0001 ), 5 min (1.90 vs 2.63, p value = <0.0001 ) and 7 min (1.84 vs 2.61, p value = <0.0001 ). In addition, it is submitted that treatment with DEXTENZA consistently resulted in lower ocular mean itching scores relative to placebo vehicle at all other study visits throughout the duration of the respective studies.

    DEXTENZA was observed to have a favorable safety profile and be generally well-tolerated in the allergic conjunctivitis, ocular inflammation and pain clinical program populations. The most common ocular adverse events seen in the pooled analysis of the allergic conjunctivitis studies were: increased intraocular pressure (n=6), increased lacrimation (n=2), eye discharge (n=2) and reduced visual acuity (n=2). The most common non-ocular adverse events seen were: headache (n=2), nasopharyngitis (n=1), gastroenteritis viral (n=1), dermatitis contact (n=1), and oropharyngeal pain (n=1).

    "The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis," said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "As DEXTENZA is physician-administered and can't be overused by patients, it provides a potentially safer method of steroid delivery. In addition, unlike current therapeutic options, DEXTENZA is a preservative-free steroid which may be a benefit for patients with allergic conjunctivitis who already have a compromised ocular surface."

    The Company has received acceptance of the sNDA submission to the FDA and anticipates a target action data under the Prescription Drug User Fee Act, commonly known as PDUFA, in October of 2021.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial evaluating DEXTENZA for the treatment of post-surgical inflammation and pain of the eye prior to its approval. Overall, 567 subjects were exposed to DEXTENZA in such clinical trials. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has completed Phase 3 clinical trials evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    1 Leonardi A, Castegnaro A, Valerio ALG, Lazzarini D. Epidemiology of allergic conjunctivitis: clinical appearance and treatment patterns in a population-based study. Curr Opin Allergy Clin Immunol. 2015;15(5):482-488.

    2 Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11(5):471-476

    3 Ora website, An Update on Ocular Allergy Trends, 2019 Ora, Inc., www.oraclinical.com

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  10. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50 per share for gross proceeds of approximately $80.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 558,750 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50 per share for gross proceeds of approximately $80.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 558,750 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is expected to close on or about December 18, 2020, subject to the satisfaction of customary closing conditions.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Raymond James & Associates, Inc. and JMP Securities LLC are acting as co-managers for the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 that became effective upon filing with the Securities and Exchange Commission (SEC). The offering is made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov, and the final prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement, the final prospectus supplement, when available, and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the underwritten public offering and the Company's anticipated use of proceeds of the offering, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the proposed underwritten public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  11. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of $75.0 million of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional $11.25 million of its common stock. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of $75.0 million of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional $11.25 million of its common stock. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

    The proposed offering is being made pursuant to a shelf registration statement on Form S-3 which became automatically effective upon filing with the Securities and Exchange Commission (SEC). This offering will be made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the proposed underwritten public offering and the Company's anticipated use of proceeds of the offering, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the final terms of the proposed underwritten offering, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the proposed underwritten public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  12. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held from December 1 to December 3, 2020.

    In addition to a fireside chat, the management team will host virtual investor meetings on Wednesday, December 2nd at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Piper Sandler representative.

    A webcast of the pre-recorded fireside chat presentation has been made available ahead of the conference and can be…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held from December 1 to December 3, 2020.

    In addition to a fireside chat, the management team will host virtual investor meetings on Wednesday, December 2nd at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Piper Sandler representative.

    A webcast of the pre-recorded fireside chat presentation has been made available ahead of the conference and can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. It will be available for replay for 90 days.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

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  13. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting being held November 13 -15, 2020.

    "We are presenting two posters and a paper at this year's American Academy of Ophthalmology (AAO) that continue to highlight Ocular Therapeutix's differentiated ophthalmology programs, including real world data on DEXTENZA® and new clinical data in OTX-TKI," said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "We are particularly encouraged with new interim Phase 1 data in…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting being held November 13 -15, 2020.

    "We are presenting two posters and a paper at this year's American Academy of Ophthalmology (AAO) that continue to highlight Ocular Therapeutix's differentiated ophthalmology programs, including real world data on DEXTENZA® and new clinical data in OTX-TKI," said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "We are particularly encouraged with new interim Phase 1 data in OTX-TKI that supports the products safety profile and demonstrates evidence of biological activity in patients with wet AMD across all three dose groups. Overall, we are thrilled with the progress we have seen in both DEXTENZA and OTX-TKI and look forward to providing additional updates on all the programs being developed with our novel hydrogel platform."

    Presentations at AAO:

    • Safety and Biological Activity of Intravitreal OTX-TKI Implant in Neovascular Age-Related Macular Degeneration (nAMD) – Phase 1 Study. D Boyer



      Interim data from the Phase 1 study continues to demonstrate that OTX-TKI has been generally well tolerated with a favorable safety profile. Evidence of biological activity is demonstrated across the three dose groups as measured by a decrease in subretinal and/or intraretinal fluid. Durability has been seen up to 11 months in one subject without the need to rescue.
    • Magnitude of Cumulative Drug Effect and Time to Resolution with an Intracanalicular Dexamethasone Insert (0.4 mg) in Pooled Phase 3 Studies. F Mah



      Data being presented continues to support DEXTENZA's rapid and consistent efficacy in the treatment of post-cataract inflammation and pain.
    • Real World Patient Experience with Dropless Steroid Therapy using a Novel Hydrogel Based Intracanalicular Dexamethasone (0.4 mg) Insert. P Majmudar



      Data from this Phase 4 real world, clinical trial demonstrates subjects undergoing cataract surgery reported high satisfaction and preference for DEXTENZA over topical drops, irrespective of administration in the operating room or outpatient clinical setting. Data collected outside conventional randomized clinical trials provides insights into adapting a novel sustained release steroid therapy into routine clinical practice.

    In addition, two posters will be presented on DEXTENZA from two of the investigator-initiated trials.

    • Dropless Punctal Plug Dexamethasone, Intracameral Ketorolac and Moxifloxacin Compared to Conventional Topical Therapy in Cataract Surgery. Donnenfeld/Hovanesian
    • Intracanalicular Dexamethasone Insert vs. Topical Steroid for the Treatment of Pain and Inflammation Following Bilateral LASIK Surgery. Greenwood

    All virtual presentations will be available for those registered starting November 11, 2020, by accessing the American Academy of Ophthalmology's 2020 Virtual Media Guide.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  14. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will participate at the following conferences:

    Raymond James SMID Cap Company Showcase
    Date: Friday, November 13, 2020
    Ocular Therapeutix™ to host investor one-on-one meetings

    Jefferies Virtual London Healthcare Conference
    Date: Thursday, November 19, 2020
    Analyst-hosted fireside chat: 5:35 PM GMT

    Management will be available throughout the day for virtual investor meetings at both conferences. If you plan to attend at least one of the conferences and are interested in meeting with management, please contact your Raymond James…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will participate at the following conferences:

    Raymond James SMID Cap Company Showcase

    Date: Friday, November 13, 2020

    Ocular Therapeutix™ to host investor one-on-one meetings

    Jefferies Virtual London Healthcare Conference

    Date: Thursday, November 19, 2020

    Analyst-hosted fireside chat: 5:35 PM GMT

    Management will be available throughout the day for virtual investor meetings at both conferences. If you plan to attend at least one of the conferences and are interested in meeting with management, please contact your Raymond James or Jefferies representative.

    A live webcast of the fireside chat during the Jefferies Virtual London Healthcare Conference can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

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  15. October Financing Raised $75.2 Million in Proceeds Net of Fees

    DEXTENZA® Net Product Revenue in Third Quarter of $5.4 Million, a 280% Increase from the Prior Quarter

    Reported Topline Phase 1 Results and Recently Initiated Phase 2 Clinical Trial of OTX-CSI for the Chronic Treatment of Dry Eye Disease

    Announced License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the quarter ended September 30, 2020 and provided a business update.

    "It has been a productive quarter for Ocular…

    October Financing Raised $75.2 Million in Proceeds Net of Fees

    DEXTENZA® Net Product Revenue in Third Quarter of $5.4 Million, a 280% Increase from the Prior Quarter

    Reported Topline Phase 1 Results and Recently Initiated Phase 2 Clinical Trial of OTX-CSI for the Chronic Treatment of Dry Eye Disease

    Announced License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the quarter ended September 30, 2020 and provided a business update.

    "It has been a productive quarter for Ocular Therapeutix with a number of key developments that we believe will drive significant long-term value," said Antony Mattessich, President and CEO. "DEXTENZA®'s momentum continues as a result of key initiatives implemented earlier in the year and exemplified by a robust 280% increase over the prior quarter. This momentum has continued into the fourth quarter with nearly 4,200 billable inserts sold to ASCs and HOPDs in the month of October. Within our pipeline, we have four clinical-stage programs that are each highly differentiated ophthalmology specialty products in markets where current annual global sales are estimated to exceed $20 billion. Each of these programs address the key unmet need in the indication it is targeting. With an improved cash position following the completion of a successful financing in October and the recently concluded license agreement with AffaMed Therapeutics, we believe we are now in a position to fund each of these four planned programs through its respective read-out of Phase 2 clinical trial data to capture the full potential benefit of the Phase 2 value inflection."

    Recent Business Updates

    Reported the American Medical Association (AMA) has established a permanent Category I Current Procedural Terminology (CPT) procedure code for 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effective January 1, 2022. The current professional fee for CPT code 0356T is expected to remain eligible to be paid per the established local fee schedule, where available, until the newly issued CPT Category I code goes into effect on January 1, 2022.

    Completed common stock financing in late October. The Company raised $75.2 million, net of fees, from a public offering of common stock in mid-October that augments cash and cash equivalents of $70.6 million as of September 30, 2020. The Company believes it now has adequate resources to fund its four planned Phase 2 programs.

    Announced License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries. The Company announced a license agreement and a collaboration with AffaMed Therapeutics for the development and commercialization of DEXTENZA® and OTX-TIC in Greater China, South Korea, and the ASEAN markets. Under the terms of the agreement, Ocular Therapeutix is entitled to receive an upfront payment of $12 million and is eligible to receive development, regulatory and commercial milestone payments and clinical development support payments of up to $91 million in the aggregate, as well as royalties from future product sales. Royalties are tiered and range from a low-teen to low-twenties percentage.

    Key Program Updates

    OTX-TKI (axitinib intravitreal implant): OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.

    • The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial in Australia intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD.
    • Two cohorts of our Phase 1 clinical trial have been enrolled, a lower-dose cohort of 200 µg with six subjects and a higher-dose cohort of 400 µg with seven subjects. We are currently enrolling a third cohort of twelve subjects, split between parallel arms of six subjects each. Subjects in the first arm of the third cohort will receive a dose of 600 µg, and subjects in the second arm will receive a 400 µg dose combined with an anti-VEGF induction injection. The Company plans to provide a clinical update at the American Academy of Ophthalmology meeting next week.
    • The Company plans to file an exploratory IND by the end of 2020 to initiate clinical development of OTX-TKI in the U.S. and to initiate a Phase 2 clinical trial in Australia by mid-2021.

    OTX-TIC (travoprost intracameral implant): OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension.

    • The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial which is intended to evaluate the safety, biological activity, durability and tolerability of OTX-TIC for the reduction of elevated intraocular pressure in patients with primary open angle glaucoma or ocular hypertension.
    • The Company has completed the first two cohorts, has fully enrolled the third cohort to assess the impact of a faster degrading implant with the same therapeutic dose as administered in cohort one, and is enrolling a fourth cohort to assess an additional formulation with a smaller implant of OTX-TIC.
    • The Company plans to initiate a Phase 2 clinical trial for OTX-TIC in mid-2021.

    OTX-CSI (cyclosporine intracanalicular insert): OTX-CSI is a long-acting, preservative-free cyclosporine intracanalicular insert for the chronic treatment of dry eye disease.

    • The Company announced topline results for its Phase 1, U.S.-based, open label, single-center clinical trial intended to evaluate safety, tolerability, durability, and biological activity on October 8, 2020. All subjects completed the 16-week study period with no drop-outs or reported serious adverse effects. Early signs of biological activity were observed including increased tear production and improvements in the signs of dry eye as measured by corneal fluorescein staining and symptoms of dry eye as measured by eye dryness severity and frequency scores using the visual analog scale.
    • The Company has initiated a Phase 2, randomized, masked, multi-center trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus vehicle insert in approximately 105 subjects for the chronic treatment of dry eye disease. The Company expects topline results in the first half of 2022.

    OTX-DED (dexamethasone intracanalicular insert): OTX-DED incorporates the FDA-approved corticosteroid dexamethasone as an active pharmaceutical ingredient into a hydrogel, drug-eluting, preservative-free intracanalicular insert. OTX-DED is designed to release dexamethasone over a period of two-to-three weeks for the short-term treatment of the signs and symptoms of dry eye disease.

    • The Company remains on track to file a Phase 2-enabling IND by the end of 2020 and, if cleared, initiate a Phase 2 trial in the first quarter of 2021.

    DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg: DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

    • U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA in the third quarter ended September 30, 2020 of $5.4 million, a 280% sequential increase over the prior quarter. Revenue reflects a record quarter of DEXTENZA in-market sales as Ambulatory Surgery Centers (ASCs) and Hospital Outpatient Departments (HOPDs) purchased nearly 10,000 billable inserts during the period. The increases observed in the third quarter of 2020 build upon the momentum seen in the prior quarter starting in May and reflect continued increases in surgical volumes as ASCs and HOPDs strive to return to pre-COVID shutdown volumes.
    • Three Medicare Administrative Contractors (MACs) covering approximately 50% of all Medicare beneficiaries have now published physician fee schedules for the reimbursement of procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA. In addition, three of the remaining four MACs have retired their non-coverage policies for 0356T.
    • On November 4, 2020, the Company announced that the American Medical Association (AMA) CPT Editorial Panel has accepted the addition of a permanent Category I CPT procedure code to replace the currently available Category III CPT code (0356T) for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effective January 1, 2022.
    • The Company remains on track to submit an sNDA for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis by the end of 2020.

    Third Quarter Ended September 30, 2020 Financial Results

    Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $5.9 million for the third quarter as compared to $1.6 million in the second quarter. Net product revenue of DEXTENZA was $5.4 million in the third quarter versus $1.4 million in the second quarter. The Company believes the significant increase of over 280% quarter-over-quarter was driven by the continued re-opening of ACSs and HOPDs as well as the impact of the DEXTENZA rebate program and the more recent physician payment of the procedure CPT code 0356T by some of the MACs. Net product revenue of ReSure® Sealant in the third quarter was $0.5 million versus $0.2 million in the second quarter.

    Research and development expenses for the third quarter were $7.0 million versus $10.2 million for the comparable period in 2019 and primarily reflect a decrease in personnel and other unallocated costs due the organizational restructuring announced in November 2019.

    Selling and Marketing expenses for the third quarter were $6.5 million versus $6.8 million for the comparable period in 2019, stemming primarily from a decrease in travel, consulting, marketing and conference expenses as a result of the COVID-related slowdown offset somewhat by increased personnel expenses.

    General and Administrative expenses were $6.0 million in the third quarter versus $6.2 million in the comparable period in 2019, reflecting a decrease in personnel expenses offset by an increase in professional costs.

    The Company reported a net loss of $(11.9) million, or a loss of $(0.19) per share on a basic basis and $(0.21) on a diluted basis for the third quarter. This compares to a net loss of $(18.8) million, or a loss of $(0.40) per share on a basic basis and $(0.45) on a diluted basis, for the same period in 2019. The net loss for the third quarter included $2.6 million in non-cash charges for stock-based compensation and depreciation compared to $3.8 million for the same quarter in 2019. In addition, the net loss for the third quarter includes a non-cash gain of $3.8 million related to the change in the fair value of the derivative liability associated with our convertible notes.

    As of November 1, 2020, the Company had approximately 71.4 million shares outstanding.

    As of September 30, 2020, the Company had $70.6 million in cash and cash equivalents versus $84.3 million at the end of the second quarter of 2020. The cash at the end of the quarter does not include incremental cash of $75.2 million net of offering discounts, commissions and estimated expenses that was raised in a follow-on public offering of common stock that was completed in October of 2020 and the anticipated proceeds of $12 million in upfront payments from the recently announced licensing agreement with AffaMed.

    Based on current plans and including related estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses, the Company believes that existing cash and cash equivalents, as of September 30, 2020 in combination with the net proceeds from the recent equity offering, enables the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements into 2023. This cash guidance is subject to various assumptions including those related to the severity and duration of the COVID-19 pandemic and other assumptions related to revenues and expenses associated with the commercialization of DEXTENZA, and the pace and expense of our research and clinical development programs, as well as other aspects of the Company's business.

    Conference Call & Webcast Information

    Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 8255125. An archive of the webcast will be available until December 20, 2020 on the Company's website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and unit sales and other financial and operational metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue and unit sales on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

     

    Ocular Therapeutix, Inc.

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

    Nine Months Ended

     

     

    September 30,

     

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    5,876

     

    $

    829

     

    $

    10,054

     

    $

    1,971

    Total revenue, net

     

     

    5,876

     

     

    829

     

     

    10,054

     

     

    1,971

    Costs and operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product revenue

     

     

    450

     

     

    806

     

     

    1,403

     

     

    1,486

    Research and development

     

     

    6,951

     

     

    10,235

     

     

    21,070

     

     

    30,966

    Selling and marketing

     

     

    6,520

     

     

    6,777

     

     

    19,803

     

     

    17,349

    General and administrative

     

     

    5,961

     

     

    6,155

     

     

    16,282

     

     

    16,571

    Total costs and operating expenses

     

     

    19,882

     

     

    23,973

     

     

    58,558

     

     

    66,372

    Loss from operations

     

     

    (14,006)

     

     

    (23,144)

     

     

    (48,504)

     

     

    (64,401)

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    6

     

     

    308

     

     

    162

     

     

    1,016

    Interest expense

     

     

    (1,715)

     

     

    (1,651)

     

     

    (5,042)

     

     

    (4,296)

    Change in fair value of derivative liability

     

     

    3,771

     

     

    5,717

     

     

    (16,640)

     

     

    7,334

    Other income (expense), net

     

     

     

     

    (8)

     

     

     

     

    (8)

    Total other income (expense), net

     

     

    2,062

     

     

    4,366

     

     

    (21,520)

     

     

    4,046

    Net loss and comprehensive loss

     

    $

    (11,944)

     

    $

    (18,778)

     

    $

    (70,024)

     

    $

    (60,355)

    Net loss per share, basic

     

    $

    (0.19)

     

    $

    (0.40)

     

    $

    (1.22)

     

    $

    (1.37)

    Weighted average common shares outstanding, basic

     

     

    62,992,558

     

     

    46,944,536

     

     

    57,440,885

     

     

    44,052,470

    Net loss per share, diluted

     

    $

    (0.21)

     

    $

    (0.45)

     

    $

    (1.22)

     

    $

    (1.37)

    Weighted average common shares outstanding, diluted

     

     

    68,761,790

     

     

    52,713,768

     

     

    57,440,885

     

     

    44,052,470

    Ocular Therapeutix, Inc.

    Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    September 30,

     

    December 31,

     

     

    2020

     

    2019

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    70,642

     

    $

    54,437

    Accounts receivable, net

     

     

    7,779

     

     

    2,548

    Inventory

     

     

    1,154

     

     

    954

    Prepaid expenses and other current assets

     

     

    2,328

     

     

    2,231

    Total current assets

     

     

    81,903

     

     

    60,170

    Property and equipment, net

     

     

    8,490

     

     

    10,151

    Restricted cash

     

     

    1,764

     

     

    1,764

    Operating lease assets

     

     

    6,062

     

     

    6,655

    Total assets

     

    $

    98,219

     

    $

    78,740

    Liabilities and Stockholders' Equity (Deficit)

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    3,238

     

    $

    3,268

    Accrued expenses and other current liabilities

     

     

    12,165

     

     

    7,635

    Operating lease liabilities

     

     

    1,297

     

     

    1,126

    Notes payable, net of discount, current

     

     

    6,206

     

     

    Total current liabilities

     

     

    22,906

     

     

    12,029

    Operating lease liabilities, net of current portion

     

     

    7,909

     

     

    8,905

    Derivative liability

     

     

    28,764

     

     

    12,124

    Notes payable, net of discount

     

     

    18,964

     

     

    25,007

    2026 convertible notes, net

     

     

    23,802

     

     

    24,305

    Total liabilities

     

     

    102,345

     

     

    82,370

    Commitments and contingencies

     

     

     

     

     

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2020 and December 31, 2019

     

     

     

     

    Common stock, $0.0001 par value; 100,000,000 shares authorized and 63,070,980 and 50,333,559 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

     

     

    6

     

     

    5

    Additional paid-in capital

     

     

    449,507

     

     

    379,980

    Accumulated deficit

     

     

    (453,639)

     

     

    (383,615)

    Total stockholders' deficit

     

     

    (4,126)

     

     

    (3,630)

    Total liabilities and stockholders' equity (deficit)

     

    $

    98,219

     

    $

    78,740

     

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  16. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that its application for the creation of a Category I Current Procedural Terminology (CPT) procedure code, presented at the October 2020 American Medical Association (AMA) CPT Editorial Panel (Panel) meeting, has been granted. The Panel has accepted the addition of a permanent Category I CPT procedure code to replace the currently available Category III CPT code (0356T) for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effective January 1, 2022.

    Compelling…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that its application for the creation of a Category I Current Procedural Terminology (CPT) procedure code, presented at the October 2020 American Medical Association (AMA) CPT Editorial Panel (Panel) meeting, has been granted. The Panel has accepted the addition of a permanent Category I CPT procedure code to replace the currently available Category III CPT code (0356T) for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effective January 1, 2022.

    Compelling clinical evidence, widespread utilization, and physician society support are required in obtaining a permanent CPT code. Category I codes normally have a standardized Medicare physician fee schedule, and as a result are anticipated to improve coverage and payment across all payers for procedures performed in both the ASC and physician office settings.

    "This is an important milestone towards establishing an appropriate coding and reimbursement environment for our intracanalicular products and in realizing our goal of replacing eye drops for certain conditions," commented Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "The recognition by the AMA that a separate code should be available for the placement of these inserts affirms this novel route of administration. We believe Category I status for the procedure of inserting a drug eluting insert into the lacrimal canaliculus delivers immediate benefits for not only DEXTENZA, but also for the other product candidates in our pipeline portfolio that are designed to utilize the same route of administration, including our two programs in dry eye disease."

    Prior to the January 1, 2022 effective date of the newly issued Category I CPT code, payments to physicians are expected to continue with the service reported using CPT code 0356T.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and unit sales and other financial and operational metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue and unit sales on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  17. Ocular Therapeutix to receive $12 million upfront fee and development and commercialization milestones and other payments of up to $91 million plus additional royalties on future product sales

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced a license agreement and a collaboration with AffaMed Therapeutics for the development and commercialization of DEXTENZA® and OTX-TIC in Greater China, South Korea, and the ASEAN markets. DEXTENZA is currently approved in the U.S. for the treatment of post-surgical ocular inflammation and pain and is being developed as a potential treatment for…

    Ocular Therapeutix to receive $12 million upfront fee and development and commercialization milestones and other payments of up to $91 million plus additional royalties on future product sales

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced a license agreement and a collaboration with AffaMed Therapeutics for the development and commercialization of DEXTENZA® and OTX-TIC in Greater China, South Korea, and the ASEAN markets. DEXTENZA is currently approved in the U.S. for the treatment of post-surgical ocular inflammation and pain and is being developed as a potential treatment for allergic conjunctivitis. OTX-TIC is in development for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

    "We are very excited to enter into this collaboration with AffaMed Therapeutics, which allows us to expand the potential and geographic reach of DEXTENZA and OTX-TIC," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "AffaMed shares our vision of developing and commercializing innovative ophthalmology products, and we look forward to leveraging their strength and reputation in Asia to bring our innovative therapies to these global markets."

    "Ocular Therapeutix is a leading ophthalmology company, and we are excited to enter into this partnership for the development and commercialization of both DEXTENZA and OTX-TIC," said Dr. Dayao Zhao, Chief Executive Officer of AffaMed Therapeutics. "AffaMed's strategy is to in-license best-in-class, highly differentiated ophthalmology products where there remains significant unmet needs."

    According to the global consulting firm IQVIA, the market for prescription ophthalmology products in China is sizeable, with $5 billion in annual sales and growth exceeding 16% per year.

    Under the terms of the agreement, Ocular Therapeutix is entitled to receive an upfront payment of $12 million and is eligible to receive development, regulatory and commercial milestone payments and clinical development support payments of up to $91 million in the aggregate, as well as royalties from future product sales. Royalties are tiered and will range from the low teens to low twenty percent range. In return, Ocular Therapeutix has agreed to grant AffaMed exclusive rights to develop and commercialize DEXTENZA for the treatment of post-surgical inflammation and pain following ophthalmic surgery and ocular itching in patients with allergic conjunctivitis, and OTX-TIC for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan; South Korea; and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam). Ocular Therapeutix retains the right to develop and commercialize DEXTENZA and OTX-TIC in all other global markets.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension, and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    About AffaMed Therapeutics

    AffaMed Therapeutics is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs in ophthalmology, and neurological and psychiatric disorders for patients in Greater China and around the world. The management team of AffaMed Therapeutics has deep industry expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. AffaMed Therapeutics was founded and funded by the CBC Group (formerly C-Bridge Capital), in 2019.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  18. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report third quarter financial results on Thursday, November 5, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 4:30 p.m. Eastern Time to review the Company’s financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report third quarter financial results on Thursday, November 5, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 4:30 p.m. Eastern Time to review the Company’s financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 8255125. An archive of the webcast will be available until December 20, 2020 on the Company’s website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company’s earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  19. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 7,180,000 shares of its common stock at a public offering price of $9.75 per share for gross proceeds of approximately $70 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,077,000 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 7,180,000 shares of its common stock at a public offering price of $9.75 per share for gross proceeds of approximately $70 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,077,000 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is expected to close on or about October 16, 2020, subject to the satisfaction of customary closing conditions.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Raymond James & Associates, Inc. and JMP Securities LLC are acting as co-managers for the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov, and the final prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement, the final prospectus supplement, when available, and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the underwritten public offering and the Company's anticipated use of proceeds of the offering, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the proposed underwritten public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  20. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares to be sold in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares to be sold in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

    The proposed offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission (SEC). This offering will be made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the proposed underwritten public offering and the Company's anticipated use of proceeds of the offering, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the final terms of the proposed underwritten offering, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the proposed underwritten public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  21. OTX-CSI demonstrates improvement in signs and symptoms of Dry Eye Disease

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).

    "The results of the Phase 1 clinical trial provide an early look at the safety, tolerability, durability, and potential biological activity of OTX-CSI," said Michael Goldstein, MD, MBA, Chief Medical Officer. "While the study enrolled a small number of subjects and was open-label, the results seen thus far are very encouraging…

    OTX-CSI demonstrates improvement in signs and symptoms of Dry Eye Disease

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).

    "The results of the Phase 1 clinical trial provide an early look at the safety, tolerability, durability, and potential biological activity of OTX-CSI," said Michael Goldstein, MD, MBA, Chief Medical Officer. "While the study enrolled a small number of subjects and was open-label, the results seen thus far are very encouraging. Our novel intracanalicular insert delivered a consistent dose of cyclosporine without preservatives over approximately 12 weeks, in a manner we believe to be both less irritating to the ocular surface and also faster acting than current standard of care eye drop therapies. We believe that if approved by the FDA, OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease and allow them a hands-free alternative to current therapies."

    The Phase 1, U.S.-based, open label, single-center clinical trial was intended to evaluate safety, tolerability, durability, and biological activity of OTX-CSI by measuring signs and symptoms of DED in five subjects (10 eyes) over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up). In the clinical trial, OTX-CSI was administered by a physician as a bioresorbable intracanalicular insert to both eyes in five subjects with DED. All subjects completed the 16-week study period with no drop-outs. No serious adverse effects were reported. The inserts were observed to be well-tolerated, and there were no adverse events of stinging, irritation, blurred vision or tearing reported or observed. Tear production as measured by the Schirmer's test improved from mean values of 4.2 mm at baseline to 8.2 mm at Week 12. One of five (20%) subjects had a ≥ 10mm increase in Schirmer's score at Week 12 from baseline. Subjects treated with OTX-CSI demonstrated an improvement in signs of DED as measured by corneal total fluorescein staining (a mean value of 6.7 at baseline, improved to a mean value of 2.7 at Week 12, on a scale of 0 to 15) and an improvement in symptoms of DED as measured by the visual analog scale (VAS) eye dryness severity score (a mean value of 51 at baseline, improved to a mean value of 33 at Week 12, on a scale of 0 to 100) and the VAS dry eye frequency score (a mean value of 51 at baseline, improved to a mean value of 31 at Week 12, on a scale of 0 to 100). The onset of action of OTX-CSI was seen as early as two weeks for both signs and symptoms of DED and continued over the 16 week study period.

    The Company recently announced that the first patient was dosed in a Phase 2, U.S.-based, randomized, masked, vehicle controlled, multi-center clinical trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks.

    About Dry Eye Disease

    Dry eye disease is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and the Market Scope 2019 Dry Eye Products Market Report estimated that more than 17.2 million adults in the United States have been diagnosed with the disorder, including an estimated 8.6 million classified as having a moderate to severe form of the disease.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  22. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported preliminary, unaudited net product revenue for the third quarter ended September 30, 2020.

    The Company is reporting preliminary third quarter 2020 total net product revenue of $5.8 to 5.9 million, representing a greater than 250 % sequential increase over the second quarter. Net product revenue of DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg and ReSure® Sealant for the quarter ended September 30, 2020, are estimated at $5.3 to 5.4 million and $0.5 million, respectively, reflecting individual product quarterly sequential growth of…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported preliminary, unaudited net product revenue for the third quarter ended September 30, 2020.

    The Company is reporting preliminary third quarter 2020 total net product revenue of $5.8 to 5.9 million, representing a greater than 250 % sequential increase over the second quarter. Net product revenue of DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg and ReSure® Sealant for the quarter ended September 30, 2020, are estimated at $5.3 to 5.4 million and $0.5 million, respectively, reflecting individual product quarterly sequential growth of net product revenue of approximately 280% and 150%, respectively. The Company expects to announce financial results for the third quarter 2020 and to provide a business update on November 5, 2020 and discuss its quarterly results in a conference call following the close of market the same day.

    Despite continued impact from the COVID pandemic, the Company had a record quarter of DEXTENZA in-market sales as Ambulatory Surgery Centers (ASCs) and Hospital Out Patient Departments (HOPDs) purchased nearly 10,000 billable inserts during the period. DEXTENZA continues to show a steady and robust rebound with the in-market sales of billable inserts into ASCs and HOPDs of 2,221, 2,920 and approximately 4,812 in July, August and September, respectively. The increases observed in the third quarter 2020 build upon the momentum seen in the prior quarter starting in May and reflect continued increases in surgical volumes as ASCs and HOPDs strive to return to pre-COVID shutdown volumes.

    "We are very pleased with the growing interest in DEXTENZA and we are encouraged by the growth in our reported sales," said Antony Mattessich, President and Chief Executive Officer. "We remain committed to serving patient needs and improving access to DEXTENZA while maintaining a strong focus on the purchase of billable units by ASCs and HOPDs since it reflects true in-market demand. For the quarter, our end-customers purchased almost 10,000 billable units with nearly half of that total coming in September. We are experiencing tremendous momentum, and we believe that there is strong receptivity to the DEXTENZA hands-free value proposition in the COVID environment."

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and unit sales and other financial and operational metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue and unit sales on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  23. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has granted a non-statutory stock option to purchase up to an aggregate of 350,000 shares of common stock of Ocular Therapeutix to a new employee, Philip C. Strassburger, as an inducement to his commencement of employment with Ocular. The award was made outside Ocular's 2014 Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock option was granted effective as of October 5, 2020, and has an exercise price of $8.42 per share, the closing price of Ocular's common stock on October 5, 2020. The stock option…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has granted a non-statutory stock option to purchase up to an aggregate of 350,000 shares of common stock of Ocular Therapeutix to a new employee, Philip C. Strassburger, as an inducement to his commencement of employment with Ocular. The award was made outside Ocular's 2014 Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock option was granted effective as of October 5, 2020, and has an exercise price of $8.42 per share, the closing price of Ocular's common stock on October 5, 2020. The stock option has a ten-year term and is scheduled to vest over four years, with 25% of the original number of shares vesting on the one-year anniversary of Mr. Strassburger's employment commencement date and the remainder vesting in equal monthly installments over the three years thereafter, subject to Mr. Strassburger's continued service to Ocular through the applicable vesting dates. The grant was approved by the Compensation Committee and each of the independent directors of Ocular Therapeutix and was made as an inducement material to his acceptance of employment with Ocular in accordance with Nasdaq Listing Rule 5635(c)(4). His stock option is subject to the terms and conditions of a stock option agreement covering the grant and Ocular's 2019 Inducement Stock Incentive Plan.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  24. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in its Phase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease.

    "Having successfully completed the Phase 1 study, we are excited to have recently begun dosing patients in the Phase 2 study of OTX-CSI," said Michael Goldstein, MD, MBA, Chief Medical Officer. "OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease. Using our novel intracanalicular insert allows for preservative-free…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in its Phase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease.

    "Having successfully completed the Phase 1 study, we are excited to have recently begun dosing patients in the Phase 2 study of OTX-CSI," said Michael Goldstein, MD, MBA, Chief Medical Officer. "OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease. Using our novel intracanalicular insert allows for preservative-free delivery of a consistent dose of cyclosporine that potentially makes OTX-CSI both less irritating to the ocular surface and faster acting than current standard of care drop therapies. If successfully developed, we believe OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease."

    The Phase 2 clinical trial is a U.S.-based, randomized, masked, multi-center trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks. The enrollment of the Phase 2 trial follows the successful completion of the U.S.-based, open-label, single-center Phase 1 study evaluating the safety, tolerability and durability of OTX-CSI and assessing biological activity by measuring signs and symptoms of dry eye disease in five subjects over approximately 16 weeks. The Phase 2 clinical trial is designed to further assess the safety, tolerability and durability and evaluate the efficacy of OTX-CSI in the treatment of dry eye disease.

    About Dry Eye Disease

    Dry eye disease is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and the Market Scope 2019 Dry Eye Products Market Report estimated that more than 17.2 million adults in the United States have been diagnosed with the disorder, including an estimated 8.6 million classified as having a moderate to severe form of the disease.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  25. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in a Phase 3 clinical trial of DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery.

    "We are pleased to announce the start of a new clinical trial designed to evaluate the use of DEXTENZA for the treatment of post-surgical inflammation and pain in children undergoing cataract surgery," said Michael Goldstein, MD, MBA, Chief Medical Officer. "Performing cataract surgery in children represents a different…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in a Phase 3 clinical trial of DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery.

    "We are pleased to announce the start of a new clinical trial designed to evaluate the use of DEXTENZA for the treatment of post-surgical inflammation and pain in children undergoing cataract surgery," said Michael Goldstein, MD, MBA, Chief Medical Officer. "Performing cataract surgery in children represents a different set of surgical and technical challenges. One area critical to surgical outcomes is postoperative medication non-compliance. It can be very challenging to successfully administer topical eye drops to children particularly when they have recently had surgery. If approved for pediatric use, DEXTENZA could provide pediatric ophthalmic surgeons with an interesting product to use to help their patients."

    The Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years. The clinical trial is designed to evaluate the safety and biological activity of DEXTENZA compared to an active control, prednisolone acetate suspension eye drops, for the treatment of postoperative inflammation and pain following ocular surgery for pediatric cataract. This planned clinical trial is a post-approval requirement of the U.S. Food and Drug Administration (FDA), in accordance with the Pediatric Research Equity Act of 2003, in connection with the FDA's prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery in adults.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

     

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  26. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced it has received a letter from the U.S. Food and Drug Administration (FDA) dated September 2, 2020 closing out the Warning Letter it received from the FDA on October 18, 2018 concerning ReSure® Sealant. The violation cited in Warning Letter (CMS #564663) has been addressed and Ocular is committed to sustained compliance with all federal regulations.

    "We are very excited to have cleared the way for ReSure's future" said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutics. "ReSure is well-regraded by anterior segment…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced it has received a letter from the U.S. Food and Drug Administration (FDA) dated September 2, 2020 closing out the Warning Letter it received from the FDA on October 18, 2018 concerning ReSure® Sealant. The violation cited in Warning Letter (CMS #564663) has been addressed and Ocular is committed to sustained compliance with all federal regulations.

    "We are very excited to have cleared the way for ReSure's future" said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutics. "ReSure is well-regraded by anterior segment surgeons and fits perfectly into the bag with Dextenza. This resolution gives us the confidence to begin active promotion of ReSure and realize the synergies of a two-product field force."

    The Warning Letter was issued to Ocular based on the observed inability to conduct a study evaluating endophthalmitis rates following ReSure use in a post-approval Device Exposure Registry study required under 21 CFR 814.82(a)(2) as a condition within the premarket approval (PMA) application. It was determined the ability to enroll a study evaluating endophthalmitis rates was prohibitively challenging due to the size of the study that would have required tens of thousands of patients. Ocular has come to an agreement with the FDA to conduct a retrospective study looking at sites with access to ReSure compared to those without access to ReSure using the American Academy of Ophthamology's Iris Registry data base.

    About ReSure® Sealant

    ReSure Sealant, a hydrogel ophthalmic wound medical device, is a product currently indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens placement in adults.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  27. Physicians in National Government Services, Inc. (NGS) jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that National Government Services, Inc. (NGS), one of seven Medicare Administrative Contractors (MACs), became the third MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible…

    Physicians in National Government Services, Inc. (NGS) jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that National Government Services, Inc. (NGS), one of seven Medicare Administrative Contractors (MACs), became the third MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the NGS website.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200904005153/en/

    (Graphic: Business Wire)

    (Graphic: Business Wire)

    "We are pleased with the continued momentum we are seeing by MACs publishing physician fee schedules for procedure code 0356T," commented Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Combined, the three MACs with published fee schedules consisting of NGS, First Coast and Novitas Solutions cover approximately 50% of all Medicare beneficiaries. This continues to be a positive development and one that could impact adoption, not only for DEXTENZA, but also for the other product candidates in our pipeline utilizing the same route of administration."

    NGS covers Medicare patients in ten states, consisting of Illinois, Minnesota, Wisconsin, New York, Massachusetts, Connecticut, New Hampshire, Maine, Rhode Island, and Vermont.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  28. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will present and host investor meetings at the following conferences:

    2020 Wells Fargo Virtual Healthcare Conference
    Date: Thursday, September 10, 2020
    Analyst-hosted fireside chat: 4:00 PM ET

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Presentation Time: 1:30 PM ET

    A live webcast of the presentations can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will present and host investor meetings at the following conferences:

    2020 Wells Fargo Virtual Healthcare Conference

    Date: Thursday, September 10, 2020

    Analyst-hosted fireside chat: 4:00 PM ET

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Presentation Time: 1:30 PM ET

    A live webcast of the presentations can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  29. Newly Published Physician Fee Schedules for 0356T for the Administration of Intracanalicular Inserts to Support Ongoing DEXTENZA® Launch

    May Financing Yields $48.3 Million in Net Proceeds

    DEXTENZA Net Product Revenue in Second Quarter of $1.4 million; Billable In-Market Sales Record Achieved in June

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

    "Despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular Therapeutix," said Antony Mattessich…

    Newly Published Physician Fee Schedules for 0356T for the Administration of Intracanalicular Inserts to Support Ongoing DEXTENZA® Launch

    May Financing Yields $48.3 Million in Net Proceeds

    DEXTENZA Net Product Revenue in Second Quarter of $1.4 million; Billable In-Market Sales Record Achieved in June

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

    "Despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular Therapeutix," said Antony Mattessich, President and CEO. "Our clinical programs continue to support potential product profiles that, if approved, we believe could become the standards-of-care in the treatment of Wet AMD, glaucoma and ocular surface diseases including dry-eye disease and allergic conjunctivitis. We also added a new program for the treatment of episodic dry eye. We have positioned ourselves to potentially enter Phase 2 trials on four major programs within the next 12 months that could, if approved, compete in some of the largest global ophthalmology markets. On the sales side, despite the global COVID-19 pandemic, we saw a welcome bounce back in DEXTENZA® sales with nearly 2,300 in-market units sold in June, exceeding our previous monthly record by 40% and eclipsing $1 million of in-market sales in a calendar month for the first time. With a new rebate program and the establishment of physician reimbursement fee schedules for the insertion of DEXTENZA at two Medicare Administrative Contractors that cover approximately 30% of the Medicare population, we expect, subject to the potential impact of the pandemic, adoption trends to accelerate in the second half of the year."

    Recent Highlights

    Announced published physician fee schedules for the administration of intracanalicular inserts. In July, the Company announced that Novitas Solutions and First Coast, two of seven Medicare Administrative Contractors (MACs) representing approximately 30% of all Medicare beneficiaries, established physician fee schedules for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. Physicians in these geographies seeking reimbursement for the administration of DEXTENZA are now eligible to be paid per the established local fee schedule. In addition, four of the remaining five MACs have retired their non-coverage policies for 0356T, and the Company believes that these MACs may publish fee schedules in the near future.

    Announced new product candidate (OTX-DED) to treat episodic dry eye disease. There are approximately 8.6 million patients diagnosed with episodic dry eye disease in the United States, according to Market Scope (2019 report). Many of these dry eye patients experience episodic flares of their signs and symptoms which the Company believes are likely related to inflammation. Currently available topical steroids may lead to adverse events such as elevated intraocular pressure (IOP) or cataracts if used chronically and all contain preservatives which can cause ocular surface toxicity, resulting in itching and burning. OTX-DED, a new product candidate with a lower dose of dexamethasone and a smaller insert size than DEXTENZA, is designed to offer these patients the opportunity, if approved, to be treated with a non-abusable, physician-administered, preservative-free and hands-free steroid therapy. Since OTX-DED has a lower concentration of dexamethasone compared with DEXTENZA, the Company is able to leverage the DEXTENZA safety package generated to date and plans to file a Phase 2-enabling Investigative New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) by the end of 2020.

    Amended collaboration with Regeneron for the development of a suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. In May, the Company amended its existing collaboration with Regeneron to develop an extended-delivery, suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. Under the new amendment, Regeneron has agreed to compensate Ocular Therapeutix on a cost-plus basis for all work performed under the pre-clinical portion of the collaboration. The back-end economics of the original agreement remain the same with the potential for option exercise fees and milestone payments of $305 million and tiered, escalating royalties from the high single digits into the low-to-mid teens.

    Completed common stock financing. In May, the Company raised $48.3 million, net of fees, from a public offering of stock. Cash and cash equivalents as of June 30, 2020 was $84.3 million and is expected to provide funding for at least the next twelve months.

    Key Program Updates

    OTX-TKI (axitinib intravitreal implant)

    OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial in Australia intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. Two cohorts of six subjects each have been enrolled, a lower-dose cohort of 200 µg and a higher-dose cohort of 400 µg.

    • In the 200 µg cohort, certain patients who had required frequent anti-VEGF dosing prior to enrollment were shown to not need rescue therapy for as long as 10 months after being treated with OTX-TKI.
    • In the 400 µg cohort, two subjects have demonstrated reduction of intraretinal and/or subretinal fluid with durability out to at least 4.5 and 7.5 months, respectively.
    • The Company is enrolling a third cohort of patients where half the subjects will be dosed at 600 µg (cohort 3a = 6 patients) and half the subjects will receive a 400 µg dose and an anti-VEGF induction injection (cohort 3b = 6 patients).
    • The Company plans to provide a Phase 1 update in the fall and is on track to submit an exploratory IND to the FDA for the U.S. by the end of 2020.

    OTX-TIC (travoprost intracameral implant)

    OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension. The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial which is intended to evaluate the safety, biological activity, durability and tolerability of OTX-TIC for the reduction of elevated IOP in patients with primary open angle glaucoma or ocular hypertension.

    • Data from the first two fully enrolled cohorts (cohort 1 = 5 patients, cohort 2 = 4 patients) have indicated a clinically meaningful reduction in mean IOP values in patients receiving OTX-TIC out to six months with durability demonstrated in one patient out to 21 months.
    • The third patient cohort (faster-degrading implant, equivalent dose to cohort 1) is now fully enrolled and the fourth patient cohort (smaller implant, lower dose) is enrolling.
    • The Company plans to initiate a Phase 2 clinical trial for OTX-TIC in the first half of 2021.

    OTX-CSI (cyclosporine intracanalicular insert)

    OTX-CSI is a long-acting cyclosporine intracanalicular insert for the treatment of chronic dry eye disease. The Company has recently initiated a Phase 1, open-label, single-center clinical trial in the United States to evaluate the safety, biological activity, durability, and tolerability of OTX-CSI for the treatment of dry eye disease.

    • The five patient cohort for the Phase 1 trial has been enrolled.
    • The safety committee has met and is supportive of moving forward with a double masked, randomized, placebo-controlled, multi-center Phase 2 trial.
    • The Company anticipates initiating a 105 patient Phase 2 clinical trial by year end.

    DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

    • U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA in the second quarter ended June 30, 2020 of $1.4 million, after a temporary shutdown in elective surgeries resulting from the COVID-19 pandemic. Despite the ongoing market challenges amid the pandemic, the Company reported its strongest month to date of DEXTENZA in-market sales in June, as Ambulatory Surgery Centers (ASCs) and hospital outpatient departments (HOPDs) purchased 2,294 billable inserts, breaking the million dollar threshold for in-market sales in a calendar month for the first time, a threshold that the Company cleared again in July. DEXTENZA has shown a steady and robust rebound with the sales of billable inserts in-market of 64, 790 and 2,294 in April, May and June, respectively, reflecting the reopening of some ASCs and HOPDs. The Company believes the market views its hands-free alternative to drops as compelling and expects to see this momentum carry over into the third quarter.
    • DEXTENZA in Allergic Conjunctivitis. The Company remains on track to meet with the FDA and plans to submit an sNDA by the end of 2020.
    • DEXTENZA for use in other ocular surface indications. There remains significant interest and excitement in evaluating DEXTENZA in many areas of unmet need with over 70 Investigator Initiated Trial (IIT) requests submitted and 14 IIT studies that are actively enrolling, including two that have completed enrollment.

    Second Quarter Ended June 30, 2020 Financial Results

    • Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $1.6 million for the three months ended June 30, 2020. Net product revenue of DEXTENZA and ReSure® Sealant in the second quarter was $1.4 million and $0.2 million, respectively.
    • Research and development expenses for the second quarter were $8.0 million versus $9.4 million for the comparable period in 2019 and primarily reflect a decrease in personnel and unallocated costs due the organizational restructuring announced in November 2019.
    • Selling and Marketing expenses for the second quarter were $6.2 million as compared to $7.2 million for the same quarter in 2019, stemming primarily from a decrease in travel, consulting, marketing and conference expenses as a result of the COVID-related slowdown in the commercialization of DEXTENZA.
    • General and Administrative expenses were $5.1 million in the second quarter of both 2020 and 2019, with a modest increase in facilities expenses being offset by decreased professional fees in Q2 2020.
    • The Company reported a net loss of $(36.6) million, or a loss of $(0.64) per share on a basic and diluted basis. This compares to a net loss of $(24.5) million, or a loss of $(0.57) per share on a basic and diluted basis, for the same period in 2019. The net loss for the second quarter included $2.5 million in non-cash charges for stock-based compensation and depreciation compared to $2.3 million for the same quarter in 2019. The net loss for the quarter includes a non-cash charge of $17.0 million related to the change in the fair value of the derivative liability associated with the Company's convertible notes, resulting primarily from the significant increase in the share price of the Company's common stock as compared to the prior quarter.
    • As of August 1, 2020, the Company had approximately 63.0 million shares outstanding.
    • As of the June 30, 2020, the Company had $84.3 million in cash and cash equivalents versus $48.2 million at the end of Q1 2020. The cash balance at June 30, 2020 reflects the addition of $48.3 million in net proceeds generated from a public offering of stock in May and net proceeds of $1.7 million from the sale of common stock under the Company's 2019 Sales Agreement under which the Company may offer and sell its common stock having aggregate proceeds of up to $50.0 million from time-to-time. Approximately $1.3 million of common stock remains available to be sold under the 2019 Sales Agreement.

    The Company believes that its existing cash and cash equivalents of $84.3 million as of June 30, 2020 will enable the Company to fund its planned operating expenses, debt service obligations and capital expenditure requirements for at least the next twelve months. This estimate is based on the Company's currently forecasted operating plan which includes estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses. These estimates are subject to various assumptions including those related to the severity and duration of the COVID-19 pandemic, a continuing expected rebound in cataract surgeries in the third quarter of 2020 and beyond, the revenues and expenses associated with the commercialization of DEXTENZA, variable expense reductions, the pace of the Company's research and clinical development programs, and other aspects of the Company's business. We have based our estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect and would therefore need to raise additional capital to support our ongoing operations or adjust our plans accordingly.

    Conference Call & Webcast Information

    Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company's financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 6937647. An archive of the webcast will be available until September 21, 2020 on the Company's website.

    About DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lacrimal punctum and into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.

    DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.

    The most commonly reported ocular adverse reactions that occurred in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

     

    Ocular Therapeutix, Inc.

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

    Six Months Ended

     

     

    June 30,

     

    June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    1,569

     

    $

    650

     

    $

    4,178

     

    $

    1,142

    Total revenue, net

     

     

    1,569

     

     

    650

     

     

    4,178

     

     

    1,142

    Costs and operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product revenue

     

     

    134

     

     

    552

     

     

    953

     

     

    680

    Research and development

     

     

    8,021

     

     

    9,414

     

     

    14,119

     

     

    20,731

    Selling and marketing

     

     

    6,153

     

     

    7,225

     

     

    13,283

     

     

    10,572

    General and administrative

     

     

    5,145

     

     

    5,058

     

     

    10,321

     

     

    10,416

    Total costs and operating expenses

     

     

    19,453

     

     

    22,249

     

     

    38,676

     

     

    42,399

    Loss from operations

     

     

    (17,884)

     

     

    (21,599)

     

     

    (34,498)

     

     

    (41,257)

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    17

     

     

    379

     

     

    156

     

     

    708

    Interest expense

     

     

    (1,694)

     

     

    (1,627)

     

     

    (3,327)

     

     

    (2,645)

    Change in fair value of derivative liability

     

     

    (17,007)

     

     

    (1,606)

     

     

    (20,411)

     

     

    1,617

    Total other income (expense), net

     

     

    (18,684)

     

     

    (2,854)

     

     

    (23,582)

     

     

    (320)

    Net loss and comprehensive loss

     

    $

    (36,568)

     

    $

    (24,453)

     

    $

    (58,080)

     

    $

    (41,577)

    Net loss per share, basic and diluted

     

    $

    (0.64)

     

    $

    (0.57)

     

    $

    (1.06)

     

    $

    (0.98)

    Weighted average common shares outstanding, basic and diluted

     

     

    57,368,292

     

     

    42,910,084

     

     

    54,634,572

     

     

    42,582,501

     

    OCULAR THERAPEUTIX, INC.

    CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    June 30,

     

    December 31,

     

     

    2020

     

    2019

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    84,294

     

    $

    54,437

    Accounts receivable, net

     

     

    2,874

     

     

    2,548

    Inventory

     

     

    1,067

     

     

    954

    Prepaid expenses and other current assets

     

     

    2,058

     

     

    2,231

    Total current assets

     

     

    90,293

     

     

    60,170

    Property and equipment, net

     

     

    8,934

     

     

    10,151

    Restricted cash

     

     

    1,764

     

     

    1,764

    Operating lease assets

     

     

    6,269

     

     

    6,655

    Total assets

     

    $

    107,260

     

    $

    78,740

    Liabilities and Stockholders' Equity (Deficit)

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    2,650

     

    $

    3,268

    Accrued expenses and other current liabilities

     

     

    5,769

     

     

    7,635

    Operating lease liabilities

     

     

    1,238

     

     

    1,126

    Notes payable, net of discount, current

     

     

    4,146

     

     

    Total current liabilities

     

     

    13,803

     

     

    12,029

    Operating lease liabilities, net of current portion

     

     

    8,256

     

     

    8,905

    Derivative liability

     

     

    32,535

     

     

    12,124

    Notes payable, net of discount

     

     

    20,970

     

     

    25,007

    2026 convertible notes, net

     

     

    26,352

     

     

    24,305

    Total liabilities

     

     

    101,916

     

     

    82,370

    Commitments and contingencies

     

     

     

     

     

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2020 and December 31, 2019

     

     

     

     

    Common stock, $0.0001 par value; 100,000,000 shares authorized and 62,953,793 and 50,333,559 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

     

     

    6

     

     

    5

    Additional paid-in capital

     

     

    447,033

     

     

    379,980

    Accumulated deficit

     

     

    (441,695)

     

     

    (383,615)

    Total stockholders' equity (deficit)

     

     

    5,344

     

     

    (3,630)

    Total liabilities and stockholders' equity (deficit)

     

    $

    107,260

     

    $

    78,740

     

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  30. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report second quarter ended June 30, 2020 financial results on Friday, August 7, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 8:30 a.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report second quarter ended June 30, 2020 financial results on Friday, August 7, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 8:30 a.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 6937647. An archive of the webcast will be available until September 21, 2020 on the Company's website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases, OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension and OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  31. Physicians in First Coast jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that First Coast Service Options, Inc. (First Coast), one of seven Medicare Administrative Contractors (MACs), became the second MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible to be paid per…

    Physicians in First Coast jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that First Coast Service Options, Inc. (First Coast), one of seven Medicare Administrative Contractors (MACs), became the second MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the First Coast website.

    "We are pleased with the continued momentum we are seeing by MACs publishing physician fee schedules for our procedure code, 0356T," commented Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Combined, First Coast and Novitas cover approximately 30% of all Medicare members. This continues to be a positive development and one that could impact adoption, not only for DEXTENZA, but also for the other product candidates in our pipeline utilizing the same route of administration."

    First Coast covers Medicare patients in Florida, Puerto Rico, and the U.S. Virgin Islands. Novitas, which the Company announced last week, covers Medicare patients in New Mexico, Texas, Colorado, Oklahoma, Arkansas, Louisiana, Mississippi, New Jersey, Pennsylvania, Delaware, Maryland, the District of Columbia, and in Virginia, Arlington and Fairfax counties and the city of Alexandria.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  32. DEXTENZA® Sets Billable Insert In-Market Sales Record in June and Company Announces Preliminary Second Quarter 2020 Net Product Revenue

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, participated in the OIS Virtual Public Company Showcase on July 16, 2020. Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, presented a corporate overview and provided updates on the DEXTENZA® launch and the product pipeline. A copy of the Company's presentation is available on the Company's website, www.ocutx.com.

    June is Record Month for DEXTENZA Billable Insert In-Market Sales; Company

    DEXTENZA® Sets Billable Insert In-Market Sales Record in June and Company Announces Preliminary Second Quarter 2020 Net Product Revenue

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, participated in the OIS Virtual Public Company Showcase on July 16, 2020. Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, presented a corporate overview and provided updates on the DEXTENZA® launch and the product pipeline. A copy of the Company's presentation is available on the Company's website, www.ocutx.com.

    June is Record Month for DEXTENZA Billable Insert In-Market Sales; Company Announces Preliminary Second Quarter 2020 Net Product Revenue

    Despite the ongoing market challenges amid COVID, the Company had its strongest month to date in DEXTENZA in-market sales in June as Ambulatory Surgery Centers (ASCs) and hospital outpatient departments purchased 2,294 billable inserts. DEXTENZA has shown a steady and robust rebound with the sales of billable inserts in-market of 64,790 and 2,294 in April, May and June, respectively. The increases observed in the second quarter reflect the reopening of some ASCs and hospitals outpatient departments and the resumption of some elective surgeries following COVID-related closures across the United States beginning in the last two weeks of March 2020.

    The Company is projecting total product net revenue of $1.6 million for the quarter ended June 30, 2020. Net product revenue of DEXTENZA (dexamethasone ophthalmic insert) 0.4mg and ReSure® Sealant for the quarter ended June 30, 2020, are estimated at $1.4 million and $0.2 million, respectively.

    "Record billable inserts sold in-market in June exceeded our previous highest month by approximately 40% and reinforces our conviction behind the launch of DEXTENZA," said Antony Mattessich, President and Chief Executive Officer. "We believe this re-established momentum in the market combined with our recent news of eligibility for professional fee reimbursement for the administration of DEXTENZA with procedure code 0356T by Novitas Solutions, the largest Medicare Administrative Contractor, positions the Company well going into the third quarter."

    Announcing New Product Candidate to Treat Episodic Dry Eye Disease

    During the presentation in the OIS Virtual Public Company Showcase, Ocular announced plans to develop a new product candidate, OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye. There are approximately 9 million patients diagnosed with episodic dry eye disease in the United States, according to Market Scope (2019 report). Many of these dry eye patients experience episodic flares of their signs and symptoms which are likely related to inflammation. Currently available topical steroids may lead to adverse events such as elevated IOP or cataracts if used chronically and all contain preservatives which result in itching and burning. We believe that OTX-DED may offer these patients the opportunity, if approved, to be treated with a self-limited, physician-administered, preservative-free and hands-free steroid therapy. The Company plans to file a Phase 2-enabling investigative new drug application with the U.S. Food and Drug Administration by the end of 2020.

    Like DEXTENZA, OTX-DED and other product candidates in the Company's pipeline that utilize the intracanalicular route of administration would potentially benefit from reimbursement under procedure code 0356T if approved.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing OTX-AFS, an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of temporary dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  33. Physicians in Novitas jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Novitas Solutions, Inc. (Novitas), one of seven Medicare Administrative Contractors (MACs), became the first MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible to be paid per the established local…

    Physicians in Novitas jurisdictions may now seek professional payment for insertion of DEXTENZA® using CPT code 0356T

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Novitas Solutions, Inc. (Novitas), one of seven Medicare Administrative Contractors (MACs), became the first MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020. The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the Novitas website.

    "We are pleased to see that physicians may now seek professional fee reimbursement for the administration of DEXTENZA and anticipate this determination could accelerate product adoption," commented Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "This is a positive development not only for DEXTENZA, but also for the other product candidates in our pipeline portfolio that utilize the same route of administration."

    Novitas covers Medicare patients in 10 states, including New Mexico, Texas, Colorado, Oklahoma, Arkansas, Louisiana, Mississippi, New Jersey, Pennsylvania, Delaware, and the District of Columbia.

    About DEXTENZA

    DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

    The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

    Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the treatment of temporary dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue and contribution on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  34. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and communities, its 2020 Annual Meeting of Stockholders (the "Annual Meeting"), to be held on Thursday, June 25, 2020 at 8:30 a.m. Eastern Time, has been changed to a virtual meeting. Stockholders will be able to participate in this year's Annual Meeting only via the virtual meeting.

    As described…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and communities, its 2020 Annual Meeting of Stockholders (the "Annual Meeting"), to be held on Thursday, June 25, 2020 at 8:30 a.m. Eastern Time, has been changed to a virtual meeting. Stockholders will be able to participate in this year's Annual Meeting only via the virtual meeting.

    As described in the proxy materials for the Annual Meeting previously distributed, you are entitled to participate in and vote at the Annual Meeting if you were a stockholder at the close of business on April 27, 2020, the record date, or hold a legal proxy for the meeting provided by the stockholder's bank, broker or nominee as of such record date. To access, participate in, and vote at the Annual Meeting at www.virtualshareholdermeeting.com/OCUL2020 (the "Annual Meeting Website"), you must enter the control number found on your proxy card, voting instruction form or notice you previously received. You may submit questions during the Annual Meeting through the virtual meeting platform in accordance with the rules of conduct made available on the Annual Meeting Website. A list of registered stockholders will also be available to record holders during the Annual Meeting at the Annual Meeting Website.

    Additional information regarding the virtual meeting is included in a proxy supplement that the company has filed today with the Securities and Exchange Commission. Please note that the proxy card included with the proxy materials previously distributed will not be updated to reflect the change in location and may continue to be used to vote your shares in connection with the Annual Meeting.

    Whether virtually attending the Annual Meeting or not, all stockholders are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. Stockholders may also vote online during the Annual Meeting by following the instructions available on the Annual Meeting Website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing OTX-IVT (aflibercept suprachoroidal injection), an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  35. Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. With the ARVO 2020 Annual Meeting being moved to a virtual format, video-recorded presentations became available online on ARVOLearn as of June 12, 2020. Additionally, abstracts will be published in the journal, Investigative Ophthalmology & Vision Science (IOVS), no later than July 31, 2020.

    "We are pleased to be presenting data on our pre-clinical and clinical programs at ARVO," commented Michael Goldstein, MD, MBA, Chief…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. With the ARVO 2020 Annual Meeting being moved to a virtual format, video-recorded presentations became available online on ARVOLearn as of June 12, 2020. Additionally, abstracts will be published in the journal, Investigative Ophthalmology & Vision Science (IOVS), no later than July 31, 2020.

    "We are pleased to be presenting data on our pre-clinical and clinical programs at ARVO," commented Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "At Ocular Therapeutix, we are excited with the progress we are making with advancing all of the programs in our pipeline. Our hydrogel platform continues to offer a patients and physicians a novel, hands free option to address both front- and back-of-the-eye diseases. We look forward to the continued progress of these programs while we continue expanding the capabilities of our diverse platform."

    Presentations at ARVO:

    • Evaluating Safety and Pharmacokinetics of OTX-CSI, a Sustained Release Intracanalicular Cyclosporine Insert in Beagles. Vanslette A et al
    • Effect of Hydrogel Persistence on Pharmacodynamics and Tolerability of OTX-TIC, Travoprost Intracameral Implant in Beagles. Langh J et al
    • Evaluating Tolerability and Pharmacokinetics of OTX-BDI, a Sustained-Release Intracanalicular Insert Co-Delivering Besifloxacin & Dexamethasone in Beagles. Rosales C et al
    • Evaluation of the Safety and Efficacy of OTX-TP, an intracanalicular travoprost insert, for the treatment of patients with open-angle glaucoma or ocular hypertension: A Phase 3 Study. Vantipalli S et al

    The online presentations will be hosted in the Media library catalog within ARVOLearn.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing OTX-IVT (aflibercept suprachoroidal injection), an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the presentation of data on the Company's products and product candidates at medical conferences; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

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  36. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate virtually in the Ophthalmology Panel at the Raymond James Human Health Innovation Conference on Monday, June 15, 2020 at 12:00 PM EDT.

    In addition to the presentation, the management team will host virtual investor meetings at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Raymond James representative.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate virtually in the Ophthalmology Panel at the Raymond James Human Health Innovation Conference on Monday, June 15, 2020 at 12:00 PM EDT.

    In addition to the presentation, the management team will host virtual investor meetings at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Raymond James representative.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA for this additional indication by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing on OTX-IVT (aflibercept suprachoroidal injection), an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  37. Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 2:30 PM EDT.

    In addition to the presentation, the management team will host investor meetings at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Jefferies representative.

    A live webcast of the presentation can be accessed by visiting the Investors…

    Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 2:30 PM EDT.

    In addition to the presentation, the management team will host investor meetings at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Jefferies representative.

    A live webcast of the presentation can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA® (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA for this additional indication by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing on OTX-IVT (aflibercept suprachoroidal injection), an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

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  38. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 8,181,819 shares of its common stock at a public offering price of $5.50 per share for gross proceeds of approximately $45 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,227,272 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 8,181,819 shares of its common stock at a public offering price of $5.50 per share for gross proceeds of approximately $45 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,227,272 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is expected to close on or about May 22, 2020, subject to the satisfaction of customary closing conditions.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Raymond James & Associates, Inc., JMP Securities LLC and H.C. Wainwright & Co., LLC are acting as co-managers for the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov, and the final prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement, the final prospectus supplement, when available, and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include OTX-CSI, an intracanalicular cyclosporine insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the underwritten public offering, the Company's anticipated use of proceeds of the offering, the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the Company's intention to file an sNDA for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

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  39. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares to be sold in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of its common stock. In addition, the Company is expected to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares to be sold in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

    The proposed offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission (SEC). This offering will be made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include OTX-CSI, an intracanalicular cyclosporine insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the proposed underwritten public offering, the Company's anticipated use of proceeds of the offering, the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the Company's intention to file an sNDA for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the final terms of the proposed underwritten offering, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the public offering and the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

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  40. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in its Phase 1 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).

    "We are pleased to be advancing OTX-CSI in the chronic treatment of dry eye disease," said Michael Goldstein, MD, MBA, Chief Medical Officer. "We believe that the intracanalicular route of administration could provide key benefits in all ocular surface diseases but particularly in dry eye. The intracanalicular route allows for preservative-free delivery of a constant dose…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in its Phase 1 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).

    "We are pleased to be advancing OTX-CSI in the chronic treatment of dry eye disease," said Michael Goldstein, MD, MBA, Chief Medical Officer. "We believe that the intracanalicular route of administration could provide key benefits in all ocular surface diseases but particularly in dry eye. The intracanalicular route allows for preservative-free delivery of a constant dose of cyclosporine, so it may be less irritating to the ocular surface than drop therapies. Also, blocking the punctum is a common treatment for DED itself and can provide immediate relief of symptoms. By being less-irritating and faster-acting than current therapies, we believe OTX-CSI has the potential to become a highly differentiated treatment that, if successfully developed, would significantly increase patient satisfaction."

    The Phase 1 clinical trial is a U.S.-based, open label, single center trial that intends to enroll 5 subjects and follow them for approximately 4 months. The study will evaluate safety and tolerability of OTX-CSI and assess biological activity by measuring signs and symptoms of DED over this time period. OTX-CSI is administered by a physician as a bioresorbable intracanalicular insert and is designed to release drug to the ocular surface for up to 3 months. After all subjects in the Phase 1 trial have been followed for at least two weeks, the safety committee will meet prior to proceeding to a U.S.-based, randomized, masked, multi-center Phase 2 clinical trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects. The Company anticipates initiating the Phase 2 clinical trial in the fourth quarter of 2020.

    About Dry Eye Disease

    Dry eye is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and it is estimated that more than 19 million adults in the United States have been diagnosed with the disorder and an estimated 7 million classified as having a moderate to severe form of the disease.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include OTX-CSI, an intracanalicular cyclosporine insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

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  41. Presentations to cover DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery and OTX-TIC in glaucoma

    Late-breaking abstract accepted detailing topline Phase 3 data for the use of DEXTENZA in the treatment of ocular itching associated with allergic conjunctivitis

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple presentations at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting, May 16-17, 2020.

    "We are thrilled with the clinical benefits we have seen with DEXTENZA for the treatment of inflammation and…

    Presentations to cover DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery and OTX-TIC in glaucoma

    Late-breaking abstract accepted detailing topline Phase 3 data for the use of DEXTENZA in the treatment of ocular itching associated with allergic conjunctivitis

    Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple presentations at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting, May 16-17, 2020.

    "We are thrilled with the clinical benefits we have seen with DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery as well as the results from the recently disclosed Phase 3 clinical trial for ocular itching associated with allergic conjunctivitis," commented Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "The presentations at ASCRS highlight both the physician and patient experiences with DEXTENZA, as well as its clinical benefit in the operating room and potentially in the office setting. We are also excited about the acceptance of our late-breaking abstract and the ability to present Phase 3 data on DEXTENZA in allergic conjunctivitis. In addition, the data being presented in glaucoma continue to highlight the strength of our hydrogel platform that is used throughout our pipeline of product candidates being developed for both front- and back-of-the-eye diseases."

    Paper Presentations at ASCRS:

    • Dropless Punctal Plug Dexamethasone, Intracameral Ketorolac and Moxifloxacin Compared to Conventional Topical Therapy in Cataract Surgery. Donnenfeld ED, Hovanesian JA, Hummel CD, Quintero JA

      Saturday May 16, 2020; 9:05 AM – 9:10 AM

      VM-1, Virtual Room 4
    • Patient and Physician Preference for an Intracanalicular Dexamethasone Insert for Treating Inflammation and Pain Following Cataract Surgery. McCabe CM, Berdahl JP, Tyson S, Singh IP, Vantipalli S, Metzinger JL, Goldstein MH

      Saturday, May 16, 2020; 9:10 AM – 9:15 AM

      VM-1, Virtual Room 4
    • Assessment of the Cumulative DEXTENZA Drug Effect Compared to Placebo in the Pooled Phase 3 Studies via Area Under the Curve (AUC) Analysis. Mah F, Feng MT, Raizman M, Silverstein B, Vantipalli S, Metzinger JL, Goldstein MH, Gibson AA

      Saturday, May 16, 2020; 9:15 AM – 9:20 AM

      VM-1, Virtual Room 4
    • Resolution of Inflammation and Pain Following Cataract Surgery with an Intracanalicular Dexamethasone Insert. Khandelwal SS, Levenson JH, Gira JP, Vantipalli S, Metzinger JL, Goldstein MH

      Saturday, May 16, 2020; 9:20 AM – 9:25 AM

      VM-1, Virtual Room 4
    • Vision Outcomes Following Cataract Surgery with an Intracanalicular Dexamethasone Insert for Treating Postoperative Inflammation and Pain. Silverstein SM, Hovanesian JA, Bafna S, Epitropoulos AT, Vantipalli S, Metzinger JL, Goldstein MH

      Saturday, May 16, 2020; 9:59 AM – 10:04 AM

      VM-1, Virtual Room 4
    • Phase 3 Trial Evaluating an Intracanalicular Dexamethasone Insert (0.4 mg) for the Treatment of Patients with Allergic Conjunctivitis. Kenyon KR, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RR, Goldstein MH

      Saturday, May 16, 2020; 10:16 AM – 10:21 AM

      VM-1, Virtual Room 4
    • Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma – Phase 1 Trial. Walters TR, Goldberg D, Bacharach J, Braun EM, Vantipalli S, Metzinger JL, Goldstein MH

      Saturday, May 16, 2020; 3:25 PM – 3:30 PM

      VM-1, Virtual Room 7

    Abstracts and full session details can be found at www.ascrs.org.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include OTX-CSI, an intracanalicular insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the presentation of data on the Company's products and product candidates at medical conferences; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

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  42. Presented Interim Clinical Data for OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity

    Announced Positive Phase 3 Clinical Trial for DEXTENZA in Allergic Conjunctivitis; Plan to File sNDA with the U.S. Food and Drug Administration by the End of 2020

    First Quarter DEXTENZA® Net Product Revenue of $2.1 million, a 31% Sequential Increase Compared with Fourth Quarter of 2019

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the first quarter ended March 31, 2020 and provided a business update.

    "The outlook for…

    Presented Interim Clinical Data for OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity

    Announced Positive Phase 3 Clinical Trial for DEXTENZA in Allergic Conjunctivitis; Plan to File sNDA with the U.S. Food and Drug Administration by the End of 2020

    First Quarter DEXTENZA® Net Product Revenue of $2.1 million, a 31% Sequential Increase Compared with Fourth Quarter of 2019

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the first quarter ended March 31, 2020 and provided a business update.

    "The outlook for Ocular continues to brighten," said Antony Mattessich, President and CEO. "As our development programs continue to perform in the clinic, changes in the regulatory and competitive landscapes give us even more confidence in our future. Successes in our clinical programs have us tracking toward target product profiles that could set the standard of care in disease areas like wet AMD, glaucoma, dry eye, and post-operative pain and inflammation while changes in the external environment make us more confident in the regulatory pathways and potential market acceptability of our programs. Similarly, concern over infection risk brought on by the COVID pandemic has sparked increased interest in truly "hands free" products like DEXTENZA that can replace 70 eye drops with a single physician-administered bioresorbable insert. As we see surgery centers and hospitals starting to schedule ophthalmic surgeries again, we are excited about our prospects of not only regaining but accelerating the momentum we saw through the middle of March for DEXTENZA."

    COVID-19 Update

    • In March 2020, the Company enacted a mandatory "work from home" policy for employees and continues to comply with national and local guidelines.
    • The Company has provided training for its staff in safety precautions and supplied personal protective equipment to ensure employee and customer safety as ambulatory surgery centers begin reopening.
    • The Company believes there has been limited impact from COVID-19 to date on its ongoing clinical programs. Enrollment in the Phase 1 clinical trial of OTX-TIC in patients with primary open angle glaucoma or ocular hypertension has recently slowed but the Company believes enrollment in Cohort 4 will not be materially impacted and currently anticipates enrollment to pick up as ophthalmology practices begin to resume normal operations.
    • The global COVID-19 pandemic has impacted recent DEXTENZA sales trends. Restrictions on cataract surgeries due to the pandemic significantly reduced our sales in late March. Despite recent elective surgery restrictions being lifted in certain geographies, the Company anticipates current guidelines and recommendations from the global health authorities will significantly impact revenue in the second quarter.

    Key Program Updates

    OTX-TKI (tyrosine kinase inhibitor intravitreal implant containing axitinib)

    OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. The Company is currently running a Phase 1, prospective, multi-center, open-label, dose escalation clinical trial intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. Two cohorts of six subjects each have been enrolled, a lower-dose cohort of 200 ug and a higher-dose cohort of 400 ug.

    • Interim data were presented by Robert Avery, MD, a member of the Phase 1 Data Safety Monitoring Committee, at the 8th Annual Vit Buckle Society Meeting on April 20, 2020.
    • The first two patients in the second, or higher-dose, cohort have shown a clinically meaningful reduction in intraretinal and/or subretinal fluid out to four and half months with a single implant. Other patients in the second cohort continue to be evaluated and have yet to reach this timepoint. As is typical of such early stage trials, visual acuity has not shown consistent improvement across the cohort.
    • If the durability and safety of OTX-TKI are confirmed in larger trials out to the four and half month time point or beyond, the Company believes that this product candidate, if approved, would have the potential to become a new standard of treatment for wet AMD.
    • Data from both cohorts continue to demonstrate that OTX-TKI has been generally well tolerated and is observed to have a favorable safety profile, with no ocular serious adverse events to date.
    • The Company completed a protocol amendment in April 2020 to enroll a third cohort of patients to be dosed at 600 µg and anticipates commencing enrollment of the third cohort by the middle of the year.

    OTX-TIC (intracameral travoprost implant)

    OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension. The Company is currently enrolling a Phase 1, prospective, multi-center, open-label, dose escalation clinical trial which is intended to evaluate the safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension.

    • Data from the first two fully enrolled cohorts (cohort 1 = 5 patients, cohort 2 = 4 patients) continue to indicate a clinically meaningful reduction in mean IOP values in patients receiving OTX-TIC.
    • The data also continue to show that the mean IOP values remained lowered from baseline through and beyond the six-month study period in many patients and, in one patient, over 18 months.
    • Enrollment in the third patient cohort is completed. Enrollment in the fourth cohort has been initiated but, due to COVID-19, is experiencing temporary delays. The Company believes enrollment will pick-up as ophthalmic offices open back up for non-emergent patients by the end of the second quarter. Long-term evaluation remains ongoing in the first two cohorts.
    • The Company believes there is an established clinical and regulatory pathway for OTX-TIC.

    DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

    • U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA® in the first quarter ended March 31, 2020 of $2.1 million versus $1.6 million in the fourth quarter ended December 31, 2019, a 31% sequential increase. First quarter 2020 revenue was negatively impacted by a rapid deceleration of DEXTENZA orders in the second half of March due to COVID-19 and stoppage of elective surgical procedures at ambulatory surgery centers and hospitals. Despite recent elective surgery restrictions being lifted in certain geographies, the Company anticipates current guidelines and recommendations from the global health authorities will significantly impact revenue in the second quarter.
    • DEXTENZA in Allergic Conjunctivitis. The Company announced positive topline results from its Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA® for the treatment of ocular itching associated with allergic conjunctivitis (AC).
      • DEXTENZA-treated subjects demonstrated a statistically significant difference in ocular itching scores (p<0.0001) compared to vehicle-treated subjects at all three pre-specified time points of 3 minutes, 5 minutes and 7 minutes on Day 8 (afternoon).
      • Upon the completion of the analysis of the Phase 3 data, the Company plans to request a meeting with the FDA and intends to submit an sNDA by the end of 2020.
      • The potential expansion of DEXTENZA with an office-setting indication highlights the versatility of the product and the opportunity for the Company's technology to potentially be used in other ocular surface diseases.
    • DEXTENZA for use in other ocular surface indications. Third-party clinical investigators have initiated nine trials to study the use of DEXTENZA in cataract surgery and other potential indications. The first trial to fully enroll is a study comparing DEXTENZA to current standard of care, prednisolone acetate, for patients who have undergone LASIK surgery. The remaining eight trials are all currently enrolling and treated patients are being followed.

    OTX-CSI (cyclosporine intracanalicular insert)

    The Company has recently initiated a Phase 1, open label, single center clinical trial in the United States to evaluate the safety, biological activity, durability, and tolerability of OTX-CSI for the treatment of dry eye disease. We expect to dose the first subject in the second quarter of 2020. The Company believes that the well-known efficacy of cyclosporine combined with the punctal occlusion of an intracanalicular insert could represent an attractive product if proven to be safe and efficacious.

    First Quarter Ended March 31, 2020 Financial Results

    • Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $2.6 million for the three months ended March 31, 2020. Net product revenue of DEXTENZA® and ReSure® Sealant in the first quarter were $2.1 million and $0.5 million respectively. Total net product revenue of $2.6 million for the quarter compares to $0.5 million for the same quarter in 2019, as DEXTENZA sales did not begin until late in the second quarter of 2019.
    • Research and development expenses for the first quarter were $6.1 million versus $11.3 million for the comparable period in 2019 and primarily reflect a decrease in personnel and unallocated costs due the organizational restructuring announced in November 2019.
    • Selling and marketing expenses for the first quarter were $7.1 million as compared to $3.3 million for the same quarter in 2019. This increase relates almost entirely to support of the commercial launch of DEXTENZA, driven primarily by the full impact of the hiring of new members of the commercial team including Key Account Managers, Field Reimbursement Managers and Medical Sales Liaisons beginning in the second quarter of 2019.
    • Finally, general and administrative expenses were $5.2 million for the first quarter of 2020 versus $5.4 million in the comparable quarter of 2019. The decrease in expenses for the quarter stemmed primarily from decreased professional costs.
    • The Company reported a net loss of $(21.5) million, or a loss of $(0.41) per share on a basic and diluted basis for the first quarter of 2020. This compares to a net loss of $(17.1) million, or a loss of $(0.41) per share on a basic and $(0.45) per share on a diluted basis, for the same period in 2019. The net loss for the first quarter included $2.3 million in non-cash charges for stock-based compensation and depreciation compared to $2.5 million for the same quarter in 2019. In addition, the net loss for the quarter, includes a non-cash charge of $3.4 million related to the change in the fair value of the derivative liability associated with the Company's convertible notes as compared to a gain of $3.2 million in the same period in 2019.
    • As of May 1, 2020, the Company had approximately 53.4 million shares outstanding.
    • As of the March 31, 2020, the Company had $48.2 million in cash and cash equivalents versus $54.4 million at year end 2019. These cash amounts exclude restricted cash of $1.8 million. The cash balance benefited during the first quarter from $12.7 million in net proceeds generated from the sale of common stock under the Company's 2019 Sales Agreement with Jefferies LLC. For the period from March 31 to May 7, 2020, the Company has sold additional common stock under the 2019 Sales Agreement generating net proceeds of $1.7 million; approximately $1.3 million of common stock remains available to be sold under the 2019 Sales Agreement.
    • Based on current plans including related estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses, the Company believes that existing cash and cash equivalents, as of March 31, 2020, together with the second quarter 2020 net proceeds through May 7th from sales of common stock pursuant to its 2019 Sales Agreement highlighted previously, will enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2021. This cash guidance is subject to various assumptions including those related to the severity and duration of the COVID-19 pandemic, an expected rebound in cataract surgeries beginning in the third quarter and other assumptions related to revenues and expenses associated with the commercialization of DEXTENZA, variable expense reductions and the pace of research and clinical development programs, and other aspects of the Company's business.

    Conference Call & Webcast Information

    Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company's financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 2083975. An archive of the webcast will be available until August 6, 2020 on the Company's website.

    About DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lower lacrimal punctum and into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.

    DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.

    The most commonly reported ocular adverse reactions that occurred in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include OTX-CSI, an intracanalicular insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

     

    Ocular Therapeutix, Inc.

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

     

    March 31,

     

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

    Product revenue, net

     

    $

    2,609

     

    $

    492

    Total revenue, net

     

     

    2,609

     

     

    492

    Costs and operating expenses:

     

     

     

     

     

     

    Cost of product revenue

     

     

    819

     

     

    128

    Research and development

     

     

    6,098

     

     

    11,317

    Selling and marketing

     

     

    7,130

     

     

    3,347

    General and administrative

     

     

    5,176

     

     

    5,358

    Total costs and operating expenses

     

     

    19,223

     

     

    20,150

    Loss from operations

     

     

    (16,614)

     

     

    (19,658)

    Other income (expense):

     

     

     

     

     

     

    Interest income

     

     

    139

     

     

    329

    Interest expense

     

     

    (1,633)

     

     

    (1,018)

    Change in fair value of derivative liability

     

     

    (3,404)

     

     

    3,223

    Total other income (expense), net

     

     

    (4,898)

     

     

    2,534

    Net loss and comprehensive loss

     

    $

    (21,512)

     

    $

    (17,124)

    Net loss per share, basic

     

    $

    (0.41)

     

    $

    (0.41)

    Weighted average common shares outstanding, basic

     

     

    51,900,882

     

     

    42,251,292

    Net loss per share, diluted

     

    $

    (0.41)

     

    $

    (0.45)

    Weighted average common shares outstanding, diluted

     

     

    51,900,882

     

     

    44,174,369

     

    OCULAR THERAPEUTIX, INC.

    CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

     

     

    March 31,

     

    December 31,

     

     

    2020

     

    2019

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    48,152

     

    $

    54,437

    Accounts receivable, net

     

     

    3,429

     

     

    2,548

    Inventory

     

     

    1,107

     

     

    954

    Prepaid expenses and other current assets

     

     

    2,465

     

     

    2,231

    Total current assets

     

     

    55,153

     

     

    60,170

    Property and equipment, net

     

     

    9,473

     

     

    10,151

    Restricted cash

     

     

    1,764

     

     

    1,764

    Operating lease assets

     

     

    6,467

     

     

    6,655

    Total assets

     

    $

    72,857

     

    $

    78,740

    Liabilities and Stockholders' Deficit

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    2,839

     

    $

    3,268

    Accrued expenses and other current liabilities

     

     

    5,018

     

     

    7,635

    Operating lease liabilities

     

     

    1,181

     

     

    1,126

    Notes payable, net of discount, current

     

     

    2,074

     

     

    Total current liabilities

     

     

    11,112

     

     

    12,029

    Operating lease liabilities, net of current portion

     

     

    8,590

     

     

    8,905

    Derivative liability

     

     

    15,528

     

     

    12,124

    Notes payable, net of discount

     

     

    22,987

     

     

    25,007

    2026 convertible notes, net

     

     

    25,299

     

     

    24,305

    Total liabilities

     

     

    83,516

     

     

    82,370

    Commitments and contingencies

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2020 and December 31, 2019, respectively

     

     

     

     

    Common stock, $0.0001 par value; 100,000,000 shares authorized and 53,037,703 and 50,333,559 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

     

     

    5

     

     

    5

    Additional paid-in capital

     

     

    394,463

     

     

    379,980

    Accumulated deficit

     

     

    (405,127)

     

     

    (383,615)

    Total stockholders' deficit

     

     

    (10,659)

     

     

    (3,630)

    Total liabilities and stockholders' deficit

     

    $

    72,857

     

    $

    78,740

     

     

    View Full Article Hide Full Article
  43. Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report first quarter ended March 31, 2020 financial results on Friday, May 8, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 8:30 a.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure…

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report first quarter ended March 31, 2020 financial results on Friday, May 8, 2020. Following distribution of the earnings release via wire services, the Ocular Therapeutix management team will host a live conference call and webcast at 8:30 a.m. Eastern Time to review the Company's financial results and provide a general business update.

    The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 2083975. An archive of the webcast will be available until August 6, 2020 on the Company's website.

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage assets include OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    View Full Article Hide Full Article
  44. Data from Phase 3 clinical trial demonstrate statistically significant effect achieved at all pre-specified primary endpoints

    The Company intends to submit an sNDA to expand DEXTENZA's label to include the treatment of ocular itching associated with allergic conjunctivitis in 2020

    Conference call and webcast to take place today at 8:30 a.m. ET

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced topline results from its Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA® for the treatment of ocular itching associated with allergic conjunctivitis (AC). We believe…

    Data from Phase 3 clinical trial demonstrate statistically significant effect achieved at all pre-specified primary endpoints

    The Company intends to submit an sNDA to expand DEXTENZA's label to include the treatment of ocular itching associated with allergic conjunctivitis in 2020

    Conference call and webcast to take place today at 8:30 a.m. ET

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced topline results from its Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA® for the treatment of ocular itching associated with allergic conjunctivitis (AC). We believe our product DEXTENZA for AC has potential as a hands-free therapy administered in the office setting as a bioresorbable, intracanalicular insert, designed to release the corticosteroid dexamethasone to the ocular surface for up to 30 days. In the Phase 3 trial, DEXTENZA met all pre-specified primary endpoints as demonstrated by a statistically significant mean change in ocular itching from baseline, on a subject-reported 5-point scale, at three time points on Day 8.

    "We are thrilled with the results from the Phase 3 clinical trial and believe the data highlights a compelling product profile that could potentially change the current standard of care with a one-time, long-acting, hands-free, therapy for the treatment of allergic conjunctivitis," said Michael Goldstein, MD, Chief Medical Officer. "The allergic conjunctivitis market is currently dominated by topical antihistamine/mast cell stabilizers. There is a large unmet need for a potent, hands-free and preservative-free topical anti-inflammatory medication for those subjects who need more than what it is currently available to them. Even in normal times, the hassle of using topical eye-drops for patients and the worry of non-compliance for physicians are problematic. In the era of COVID-19, having a full course of steroid treatment in a single physician-administered insert that doesn't require patients to touch their face multiple times per day is an even greater breakthrough."

    "Approximately 10-15 % of my allergic conjunctivitis patients are not adequately controlled with current therapy and thus require use of topical steroids. This patient group comprises commonplace seasonal and perennial allergic conjunctivitis as well as more severe atopic and vernal keratoconjunctivitis," stated Ken Kenyon, MD, an investigator in the DEXTENZA trial and Clinical Professor of Ophthalmology at Tufts / New England Eye Center. "Having a potent and effective anti-inflammatory medication to personally administer in the office setting without concern for patient compliance or potential misuse would be a great addition to my therapeutic toolbox."

    The Phase 3 randomized, double-masked, parallel-arm, placebo-controlled clinical trial enrolled 96 subjects and was conducted across 6 sites in the U.S. using Ora, Inc.'s modified Conjunctival Allergen Challenge (Ora-CAC®) Model. The primary efficacy measure for this trial was ocular itching on Day 8 at 3 minutes, 5 minutes and 7 minutes post-challenge and included subjects with seasonal and perennial allergens. The trial's primary endpoint was ocular itching measured on a 5-point scale (0 to 4) at three pre-specified time points on Day 8 (PM), 1 week after insertion of DEXTENZA. DEXTENZA-treated subjects demonstrated a statistically significant (p<0.0001) change in ocular itching from baseline at all three pre-specified time points (Table 1). An assessment of the secondary endpoint of ocular itching at all other visits (Day 7, Day 8 (AM), Day 8 (PM, 10 minutes following exposure), Day 14, and Day 15 (AM and PM)) also showed that DEXTENZA-treated subjects had lower itching scores than vehicle-treated subjects at 3 minutes, 5 minutes, 7 minutes and 10 minutes post-CAC (p<.05 for all 21 time points except Day 7 at 3 minutes).

    DEXTENZA was observed to have a favorable safety profile and be well-tolerated with no serious adverse events observed (ocular or non-ocular). No subjects required rescue medication and no subjects experienced elevated intraocular pressure. There were 8 ocular treatment emergent adverse events in this trial (2 in the DEXTENZA group and 6 in the vehicle group).

    Table 1

    Primary Efficacy Endpoint Ocular Mean Itching Scores at Day 8 (PM)

    Challenge Time

    Points

    Mean Itch Scores

    Treatment

    Difference

    (DEXTENZA-Vehicle)

    P Value

    DEXTENZA

    Vehicle

    3 minutes

    1.82

    2.67

    -0.86

    <0.0001

    5 minutes

    1.73

    2.71

    -0.98

    <0.0001

    7 minutes

    1.74

    2.69

    -0.96

    <0.0001

    Least Squares Means; Population: Intent-to-treat (ITT) + Markov Chain Monte Carlo (MCMC)

    These data are consistent with what has been observed in prior Phase 2 and Phase 3a clinical trials using a similar repeat CAC model. The Company believes that the totality of the efficacy and safety data across the Phase 2 trial and the three Phase 3 trials (n = 323 subjects) represent a compelling package for discussion with the U.S. Food and Drug Administration (FDA) for the treatment of ocular itching associated with AC. This package is also supported by the safety data associated with the prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery. The Company will continue to assess additional secondary endpoints over the next several weeks. Upon completion of this review, the Company intends to request a meeting with the FDA to discuss the potential submission of a supplement to its existing new drug application for DEXTENZA to include the treatment of ocular itching associated with AC as an additional approved indication.

    "It is estimated that up to 10 million1,2,3 people in the U.S. seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete and significant potential market for DEXTENZA beyond its current use in the surgical setting," said Antony Mattessich, the Company's President and Chief Executive Officer. "In addition to managing the various facets of symptoms associated with AC, we believe that this potential product also addresses physicians' desire for an abuse-deterrent steroid and patients' desire for a hands-free solution. From a business perspective, ocular itching associated with AC represents the first indication for DEXTENZA that will be administered in the office setting and is our first potential indication in the large ocular surface disease market. The commercial potential for DEXTENZA in the treatment of ocular surface diseases like AC and episodic dry eye is greater than its potential in the surgical setting."

    Conference Call & Webcast Information

    Members of the Ocular Therapeutix management team will host a live conference call and webcast this morning at 8:30 am Eastern Time to discuss the Phase 3 clinical data announcement. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 1460319. An archive of the webcast will be available until July 28, 2020 on the Company's website.

    About DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lower lacrimal punctum and into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.

    DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.

    The most commonly reported ocular adverse reactions that occurred in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage assets include OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

    1 Leonardi A, Castegnaro A, Valerio ALG, Lazzarini D. Epidemiology of allergic conjunctivitis: clinical appearance and treatment patterns in a population-based study. Curr Opin Allergy Clin Immunol. 2015;15(5):482-488.

    2 Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11(5):471-476

    3 Ora website, An Update on Ocular Allergy Trends, 2019 Ora, Inc., www.oraclinical.com

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  45. Fourth Quarter DEXTENZA® Net Product Revenue of $1.6 million, a 433% Sequential Increase; Guiding First Quarter Total Net Product Revenue of $3.0 million to $3.2 million

    Presented Interim Clinical Data Releases for OTX-TIC and OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

    "Ocular Therapeutix has had an impressive final quarter of 2019 and strong start to 2020," said Antony…

    Fourth Quarter DEXTENZA® Net Product Revenue of $1.6 million, a 433% Sequential Increase; Guiding First Quarter Total Net Product Revenue of $3.0 million to $3.2 million

    Presented Interim Clinical Data Releases for OTX-TIC and OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity

    Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

    "Ocular Therapeutix has had an impressive final quarter of 2019 and strong start to 2020," said Antony Mattessich, President and Chief Executive Officer. "Key performance indicators on the launch of DEXTENZA point to a building momentum, most notably in the number of billable inserts ordered by ASC's and hospitals that show a definitive acceleration. We are equally excited on the product development side by interim results from our two Phase 1 programs: in our OTX-TIC program, signals support the possibility for a product that could have both the magnitude and duration of effect to become a standard of care in the treatment of elevated IOP; and, most encouragingly, in our OTX-TKI program, we have seen a signal of biologic effect, observing a reduction in sub-retinal and intra-retinal fluid in some patients with wet AMD. Both of these early programs have the potential to shift current treatment paradigms."

    Key Program Updates

    DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

    • U.S. Commercial Launch of DEXTENZA
      • The Company reported net product revenue of DEXTENZA in the fourth quarter ended December 31, 2019 of $1.6 million versus $0.3 million in the third quarter ended September 30, 2019, an amount which reflects a 433% sequential increase. DEXTENZA was commercially launched in July 2019 and received its J-code in October of the same year.
      • The Company continues to increase the number of new accounts, including seeing larger accounts adopting DEXTENZA, and the number of existing accounts re-ordering continues to increase.
      • Over the three months ended February 2020, the Company has experienced month-over-month growth in billable units of 9%, 26% and 34%.
      • The Company anticipates net product revenue of DEXTENZA for the first quarter of 2020 will be in the range of $2.4 million to $2.6 million.
    • DEXTENZA for use in other ocular surface indications
      • The Company is currently conducting a pivotal Phase 3 clinical trial for the treatment of ocular itching associated with allergic conjunctivitis. The Company has recently completed enrollment and anticipates releasing results in the second quarter of 2020. Subject to obtaining favorable results in this clinical trial, the Company plans to submit an NDA supplement to the FDA for the treatment of ocular itching associated with allergic conjunctivitis as DEXTENZA's first non-surgical indication.
      • The expansion of DEXTENZA into the office setting would highlight the versatility of the product and the opportunity for the Company's technology to potentially be used in ocular surface diseases.

    OTX-TIC (travoprost implant for intracameral injection)

    OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension. The Company presented interim data on OTX-TIC at the Glaucoma 360 Conference held in San Francisco, CA in February.

    • The Phase 1, prospective, multi-center, open-label, dose escalation clinical trial is intended to evaluate the safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated IOP in patients with primary open angle glaucoma or ocular hypertension. Data from the first two fully enrolled cohorts (cohort 1=5 subjects, cohort 2=4 subjects) indicate a clinically meaningful reduction in mean IOP values in patients receiving OTX-TIC. The data also show that the mean IOP values remained decreased from the baseline values through the six month study period and beyond and, in one patient, for up to eighteen months. This Phase 1 clinical trial is not powered to measure any efficacy endpoints with statistical significance.
    • The implant biodegraded consistently in approximately five to seven months and was generally well tolerated and observed to have a favorable safety profile in both cohorts, with no serious ocular adverse events reported.
    • Enrollment has begun in the third and fourth cohorts of the trial while continued long-term evaluation remains ongoing in the first two cohorts.

    OTX-TKI (tyrosine kinase inhibitor intravitreal implant containing axitinib)

    The Company announced interim results last week from a Phase 1 clinical trial for OTX-TKI, a bioresorbable, hydrogel implant with anti-angiogenic properties delivered by intravitreal injection to the posterior segment of the eye for wet age-related macular degeneration (wet AMD) and other retinal diseases.

    • The Phase 1, prospective, multi-center, open-label, dose escalation clinical trial is intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. Two cohorts of six subjects each have been enrolled, a lower-dose cohort of 200 ug and a higher-dose cohort of 400 ug. This Phase 1 clinical trial is not powered to measure any efficacy endpoints with statistical significance.
    • In the higher-dose cohort, a decrease in intraretinal and/or subretinal fluid was seen in some subjects treated with OTX-TKI as a monotherapy. In both cohorts, initial data showed that in subjects previously treated with anti-VEGF, OTX-TKI may extend the durability of anti-VEGF injections with no increase or decrease in fluid noted.
    • Data from the first two fully enrolled cohorts demonstrated OTX-TKI was generally well tolerated and observed to have a favorable safety profile, with no serious adverse ocular events noted.
    • Long-term evaluation of cohorts 1 and 2 will continue and the Company will be amending its current clinical trial protocol to enroll a third, higher-dose cohort.

    OTX-CSI (cyclosporine intracanalicular insert)

    The Company recently filed an IND and intends to begin a Phase 1 clinical trial by the middle of 2020 for OTX-CSI, a cyclosporine intracanalicular insert targeting dry eye disease.

    Fourth Quarter and Year Ended December 31, 2019 Financial Results

    • Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $2.3 million for the three months ended December 31, 2019, reflecting a 172% sequential increase over the third quarter ended September 30, 2019. Net product revenue of DEXTENZA in the fourth quarter 2019 was $1.6 million versus $0.3 million in the third quarter and reflects a 433% sequential increase. Total net product revenue for the fourth quarter of 2019 also includes net product revenue of $0.7 million from ReSure® Sealant. Overall net product revenue for the year ended December 31, 2019 was $4.2 million versus $2.0 million for 2018 and primarily reflects the addition of DEXTENZA sales beginning in the second quarter of 2019.
    • Research and development expenses for the fourth quarter were $10.1 million versus $10.3 million for the comparable period in 2018 and primarily reflect an increase in unallocated costs and clinical trial costs associated with the Phase 3 DEXTENZA allergic conjunctivitis trial and the Phase 1 trials for OTX-TIC and OTX-TKI offset by a significant reduction of the Phase 3 clinical trial costs associated with OTX-TP. Overall R&D expenses for the full year increased $4.2 million to $41.1 million from $36.9 million in 2018, reflecting increased unallocated costs and the trend in clinical trial expenses mentioned above.
    • Selling and marketing expenses for the fourth quarter were $7.1 million as compared to $2.3 million for the same quarter in 2018. This increase relates almost entirely to support of the commercial launch of DEXTENZA, driven primarily by the full impact of the hiring of new members of the commercial team including Key Account Managers, Field Reimbursement Managers and Medical Sales Liaisons beginning in the second quarter of 2019. Overall selling and marketing expenses for the full year increased $19.6 million to $24.5 million from $4.9 million in 2018, driven primarily by the hiring of new members of the commercial team, as highlighted above, as well as increased spending on consulting, conferences and related costs.
    • Finally, general and administrative expenses were $5.6 million for the fourth quarter of 2019 versus $5.1 million in the comparable quarter of 2018. The increase in expenses for the fourth quarter stemmed primarily from increased personnel costs. Overall, general and administrative expenses for the full year increased $3.3 million to $22.1 million from $18.8 million in 2018, again reflecting primarily increased personnel costs.
    • The Company reported a net loss of $(26.0) million, or a loss of $(0.53) per share on a basic and diluted basis for the fourth quarter of 2019. This compares to a net loss of $(17.4) million, or a loss of $(0.42) per share on a basic and diluted basis, for the same period in 2018. The net loss for the fourth quarter included $2.6 million in non-cash charges for stock-based compensation and depreciation compared to $2.5 million for the same quarter in 2018. In addition, the net loss for the quarter, includes a non-cash charge of $3.0 million related to the change in the fair value of the derivative liability associated with the Company's convertible notes. Overall, the Company reported a net loss of $86.4 million or a loss of $(1.91) per share on a basic and diluted basis for the full year ended December 31, 2019 versus a net loss of $60.0 million or a loss of $(1.57) per share on a basic and diluted basis in 2018.
    • As of March 2, 2020, the Company had 52.6 million shares outstanding.
    • As of the full year ended December 31, 2019, the Company had $54.4 million in cash and cash equivalents versus $54.1 million at year end 2018. These cash amounts exclude restricted cash of $1.8 million and $6.6 million, respectively. Restricted cash was reduced by $5.0 million in the third quarter of 2019 as a result of an amendment with the lenders of our $25.0 million term loan facility to eliminate the $5.0 million liquidity covenant. The cash balance benefited during the fourth quarter from $8.9 million in net proceeds generated from the sale of common stock under the Company's 2019 Sales Agreement under which the Company may offer and sell its common stock having aggregate proceeds of up to $50.0 million from time to time. For the full year ended December 31, 2019, cash balances benefited from total net proceeds from financing activities of $75.3 million, primarily consisting of net proceeds from the 2026 Convertible Notes of $37.3 million, common stock sales under the 2016 Sales Agreement of $4.9 million, and common stock sales under the 2019 Sales Agreement of $32.7 million. For the current calendar year through March 10, 2020, the Company has sold additional common stock under the 2019 Sales Agreement generating net proceeds of $10.7 million; approximately $5.2 million of common stock remains available to be sold under the 2019 Sales Agreement.
    • Based on current plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure product sales and cash outflows from operating expenses, the Company believes that existing cash and cash equivalents, as of December 31, 2019, together with the first quarter 2020 net proceeds through March 10th, from sales of common stock pursuant to its 2019 Sales Agreement highlighted previously, will enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2021. This cash guidance is of course subject to a number of assumptions related to the revenues and expenses associated with the commercialization of DEXTENZA as well as the pace of research and clinical development programs, and other aspects of the Company's business.

    Conference Call & Webcast Information

    Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call. The conference ID number for the live call will be 9974763. An archive of the webcast will be available until June 10, 2020 on the Company's website.

    About DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

    DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lower lacrimal punctum and into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.

    DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.

    The most commonly reported ocular adverse reactions that occurred in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).

    About Ocular Therapeutix, Inc.

    Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is conducting a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage assets include OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing a tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

    Forward Looking Statements

    Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings and need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the Company's quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.