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 the appointment of Merilee Raines to the Company's Board of Directors effective September 20, 2021.

    "We are excited to welcome Merilee to our Board of Directors," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Merilee brings a wealth of operational, financial, and business experience to our team. Having started as employee #11 at IDEXX, she helped to drive a multitude of innovative growth strategies and successfully scaled the business from start-up to the multinational it is today. Her guidance…

    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 appointment of Merilee Raines to the Company's Board of Directors effective September 20, 2021.

    "We are excited to welcome Merilee to our Board of Directors," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Merilee brings a wealth of operational, financial, and business experience to our team. Having started as employee #11 at IDEXX, she helped to drive a multitude of innovative growth strategies and successfully scaled the business from start-up to the multinational it is today. Her guidance and input will be invaluable as we seek to grow Ocular into a strategic leader in the ophthalmology space."

    Ms. Raines brings deep experience as a former public company financial executive having served 28 years with IDEXX Laboratories, Inc. (NASDAQ:IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing. During her career at IDEXX, Ms. Raines held multiple positions of increasing responsibilities and served as the Company's Executive Vice President and Chief Financial Officer at her retirement in May 2013. Ms. Raines is also an experienced independent board director and currently serves as a member of the Board of Directors of Transmedics Group, Inc. (NASDAQ:TMDX), Watts Water Technologies, Inc. (NYSE:WTS) and Excelitas Technologies Corporation, a private company. She holds a M.B.A. from University of Chicago, an A.B. from Bowdoin College and is a Certified Public Accountant (inactive status).

    "Ocular has successfully leveraged its hydrogel platform to bring an innovative product in DEXTENZA® to market and emerge as a highly-focused ophthalmology company with a pipeline of differentiated products designed to drive long-term growth," said Ms. Raines. "I am pleased to be joining Ocular and the other members of its Board during this exciting period."

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 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. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI 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 operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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 reported in-market unit sales of DEXTENZA® billable inserts of 6,924 and 9,321 in July and August, respectively, as part of the Company's corporate presentation at the H.C. Wainwright 23rd Annual Global Investment Conference. August units represent the second highest month of in-market unit sales of DEXTENZA billable inserts to date. The Company's current corporate presentation can be accessed in the Investors portion of its website at www.ocutx.com.

    The Company primarily derives product revenues from the sale of DEXTENZA to a network of authorized…

    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 in-market unit sales of DEXTENZA® billable inserts of 6,924 and 9,321 in July and August, respectively, as part of the Company's corporate presentation at the H.C. Wainwright 23rd Annual Global Investment Conference. August units represent the second highest month of in-market unit sales of DEXTENZA billable inserts to date. The Company's current corporate presentation can be accessed in the Investors portion of its website at www.ocutx.com.

    The Company primarily derives product revenues from the sale of DEXTENZA to a network of authorized specialty distributors, who then resell DEXTENZA to medical centers such as ambulatory surgery centers or hospital outpatient departments. The Company refers to such resales as in-market unit sales.

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 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. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI 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 operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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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  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 present at the H.C. Wainwright 23rd Annual Global Investment Conference being held from September 13-15, 2021.

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

    A webcast of the pre-recorded presentation will be made available the morning of the conference starting at 7:00 AM ET on Monday, September 13th, and can be accessed…

    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 H.C. Wainwright 23rd Annual Global Investment Conference being held from September 13-15, 2021.

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

    A webcast of the pre-recorded presentation will be made available the morning of the conference starting at 7:00 AM ET on Monday, September 13th, 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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 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. 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, today announced that it will participate in two panels and will provide a pre-recorded presentation at the H.C. Wainwright Ophthalmology Virtual Conference being held on Tuesday, August 17th, 2021:

    Surpassing the Standard of Care for Glaucoma Panel
    Date: Tuesday, August 17th, 2021.
    Time: 7:00 AM ET

    Emerging Therapeutics for Dry Eye Disease Panel
    Date: Tuesday, August 17th, 2021.
    Time: 2:00 PM ET

    The management team will also host virtual investor meetings on Tuesday, August 17th at the conference. Investors participating in the conference who are…

    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 in two panels and will provide a pre-recorded presentation at the H.C. Wainwright Ophthalmology Virtual Conference being held on Tuesday, August 17th, 2021:

    Surpassing the Standard of Care for Glaucoma Panel

    Date: Tuesday, August 17th, 2021.

    Time: 7:00 AM ET

    Emerging Therapeutics for Dry Eye Disease Panel

    Date: Tuesday, August 17th, 2021.

    Time: 2:00 PM ET

    The management team will also host virtual investor meetings on Tuesday, August 17th at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their H.C. Wainwright representative.

    A webcast of the pre-recorded presentation will be made available the morning of the conference starting at 7:00 AM ET on Tuesday, August 17th, 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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 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. 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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  5. DEXTENZA® Recorded Net Quarterly Sales of $11.1 Million, Representing Quarterly Sequential Growth of Approximately 65%

    Initiated First Clinical Trial in the U.S. to Assess a Single OTX-TKI Implant Containing a 600µg Dose of Axitinib for the Treatment of Wet Age-Related Macular Degeneration

    Conference Call to Discuss Second Quarter Results to be Held at 4:30 p.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 reported financial results for the second quarter of 2021, and provided updates on its ophthalmology pipeline.

    "It has been a productive quarter for Ocular as we work to build…

    DEXTENZA® Recorded Net Quarterly Sales of $11.1 Million, Representing Quarterly Sequential Growth of Approximately 65%

    Initiated First Clinical Trial in the U.S. to Assess a Single OTX-TKI Implant Containing a 600µg Dose of Axitinib for the Treatment of Wet Age-Related Macular Degeneration

    Conference Call to Discuss Second Quarter Results to be Held at 4:30 p.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 reported financial results for the second quarter of 2021, and provided updates on its ophthalmology pipeline.

    "It has been a productive quarter for Ocular as we work to build a leading ophthalmology company," said Antony Mattessich, President and Chief Executive Officer. "Net product revenue for DEXTENZA® was up nearly 700% against the prior year period and we achieved record quarterly in-market sales of nearly 25,000 billable units, representing a 50% sequential increase over the first quarter. Beyond DEXTENZA, we made significant progress in advancing our pipeline of product candidates, dosing the first patient in our U.S.-based trial of OTX-TKI, and completing a research agreement with Mosaic Biosciences targeting dry-AMD that further builds our product pipeline. In the second half of 2021, we look forward to continued momentum with DEXTENZA, including a PDUFA date in allergic conjunctivitis in October, and further development of our pipeline which includes the expected completion of our Phase 2 clinical trial with OTX-CSI, our cyclosporine-containing intracanalicular insert for the chronic treatment of dry eye disease."

    Recent Business Updates

    First Patient Dosed in U.S.-based Clinical Trial Evaluating OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet AMD. The Phase 1 clinical trial in the U.S. is a prospective, randomized, controlled, multi-center trial evaluating a single OTX-TKI implant containing a 600 µg dose of axitinib with an anti-VEGF induction injection, compared with a 2 mg dose of aflibercept administered every 8 weeks in subjects previously treated with anti-VEGF therapy. This is the first clinical trial utilizing the Company's single dose, 600 µg implant. This trial is designed to assess the safety, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD and is being conducted under an exploratory IND, at five sites with a total of 20 randomized subjects: 15 subjects being treated with a single OTX-TKI implant with an anti-VEGF induction injection, and 5 subjects being treated at eight-week intervals with a dose of aflibercept. OTX-TKI has the potential to be a novel sustained release administration of axitinib, with six months or longer durability, which includes a potential new mechanism of action for the treatment for patients with wet AMD and other retinal diseases.

    U.S. Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA® for the quarter was $11.1 million, a nearly 700% increase over the second quarter 2020, and an approximately 65% sequential increase over the first quarter of 2021. DEXTENZA in-market unit volume to surgery centers was a record of nearly 25,000 billable inserts, an approximately 50% sequential increase over the previous quarter. The Company believes this growth reflects strong end-user demand for DEXTENZA driven by an increase in cataract procedure volumes and market share gains. June 2021 in-market unit sales set a monthly record of 9,779 billable inserts as cataract volumes continued to increase through the second quarter of 2021 after a slowing of procedures earlier in the year as result of regional COVID surges. As previously reported, April and May in-market unit sales were 8,025 billable inserts and 7,186 billable inserts, respectively.

    DEXTENZA Pass-Through Payment Status Recommended for Extension Through the End of 2022. CMS, in its CY 2022 Outpatient Prospective Payment System (OPPS) proposed rule on July 19, 2021, recommended that pass-through status of DEXTENZA be extended six months through the end of 2022. The Company expects that, if finalized, this decision would move any negotiation between the Company and CMS on DEXTENZA's post-pass-through payment status into the next rulemaking cycle, a year from now. The Company continues to believe there are a number of pathways whereby it can continue to provide patient access to DEXTENZA in ASCs and HOPDs beyond the pass-through period and expects to be working actively in advance of the 2023 rulemaking cycle.

    New Medicare Physician Fee Schedule Proposed for Insertion of DEXTENZA. The Medicare Physician Fee Schedule proposed rule was also issued in July. The proposed rule indicated that the Company's CPT procedural code, 0356T for the Insertion of a drug-eluting implant into the lacrimal canaliculus, continues to be on track to convert to a Category 1 code in January of 2022 with a proposed procedure payment of $31.91 in the facility and $37.61 in the physician's office for unilateral insertion. The Company is pleased with the prospect of the Category 1 code conversion for the procedure since Category 1 CPT codes typically benefit from broader coverage and payment among all types of payers. However, the Company intends to use the formal comment period to actively pursue higher potential payment rates that it believes are well justified.

    Presented Clinical Data at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Meeting. Eight company presentations and five presentations from investigator-initiated trials were presented at the 2021 ASCRS Meeting on July 23-27th. Data was presented on multiple programs advancing in clinic as well as DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use and ReSure® Sealant. The data being presented continue to support the use of DEXTENZA to treat post-operative ocular inflammation and pain and the ability to research the use of our proprietary hydrogel technology to potentially address the unmet needs in the ophthalmic space, specifically in glaucoma, dry eye disease and allergic conjunctivitis. Posters for the Company-sponsored presentations can be accessed on the corporate website.

    Regeneron Collaboration to Develop a Sustained-Release Formulation of Aflibercept for the Treatment of Wet AMD and other Serious Retinal Diseases Terminated. Regeneron has terminated its collaboration with the Company. The collaboration with Regeneron was initially formed in 2016, and later amended in 2020 to focus on the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space for the treatment of retinal diseases. Ocular is now free to potentially pursue discovery work in this area on its own or with a partner.

    Key Program Updates

    • OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet AMD and other retinal diseases.
      • The Company dosed the first subject in the U.S.-based Phase 1 clinical trial evaluating a single OTX-TKI implant containing a 600 µg dose of axitinib compared to aflibercept administered every 8 weeks in subjects previously treated with anti-VEGF therapy.
    • OTX-TIC (travoprost intracameral implant) for the treatment of patients with primary open-angle glaucoma or ocular hypertension.
      • Following supportive data from a U.S.-based Phase 1 study, the Company is targeting the initiation of a randomized, double-masked, active-controlled Phase 2 clinical trial in the fourth quarter of 2021 in the United States.
      • The clinical trial will enroll approximately 105 subjects to evaluate two different formulations of OTX-TIC versus a control arm receiving Durysta™.
    • OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease.
      • The Company has completed enrollment of a U.S.-based Phase 2, randomized, double-masked, multi-center clinical trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus hydrogel vehicle insert.
      • Top-line data from the Phase 2 clinical trial are expected in the fourth quarter of 2021.
    • OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease.
      • The Company is enrolling a U.S.-based, prospective, randomized, double-masked, vehicle-controlled, multi-center Phase 2 clinical trial in approximately 150 subjects with dry eye disease.
      • Enrollment has been faster than anticipated and data from the Phase 2 clinical trial is now expected in the first quarter of 2022 versus prior guidance of the first half of 2022.
    • DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular itching associated with allergic conjunctivitis.
      • The FDA has set a PDUFA target action date of October 18, 2021.

    Second Quarter Ended June 30, 2021 Financial Results

    Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $11.7 million and represented a 631% increase over the same period in 2020. Net product revenue of DEXTENZA® in the second quarter was $11.1 million versus $1.4 million in the comparable quarter 2020, reflecting a nearly seven times increase. Total net product revenue for the second quarter also includes net product revenue of $0.6 million from ReSure® Sealant, compared with $0.2 million from ReSure Sealant in the comparable quarter 2020.

    Research and development expenses for the second quarter were $13.9 million versus $8.0 million for the comparable period in 2020 primarily driven by increased headcount as well as increased clinical trial costs associated with the initiation of the US-based Phase 1 trial of OTX-TKI as well as the ongoing Phase 2 clinical trials for OTX-CSI and OTX-DED, the ongoing Phase 1 clinical trial of OTX-TKI in Australia and the Phase 3 pediatric clinical trial of DEXTENZA in accordance with the FDA's post-approval requirements.

    Selling and marketing expenses in the quarter were $8.4 million as compared to $6.2 million for the same quarter in 2020, reflecting increased personnel costs associated with expansion of our field force.

    Finally, general and administrative expenses were $8.6 million for the second quarter versus $5.1 million in the comparable quarter of 2020. The increase in expenses stemmed primarily from increased personnel expenses and professional fees.

    With respect to the financial results for the second quarter, the Company reported a net loss of $8.5 million, or $(0.11) per share on a basic and $(0.25) per share on a diluted basis. This compares to a net loss of $36.6 million, or $(0.64) per share on a basic and diluted basis for the same period in 2020. The decreased loss was due primarily from a $30.4 million net change in the fair value of the derivative liability associated with our convertible note driven by a decrease in the price of our common stock during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization was $4.9 million in the second quarter versus $2.5 million for the same quarter in 2020.

    As of August 4, 2021, the Company had 76.6 million shares outstanding.

    As of June 30, 2021, the Company had $191.9 million in cash and cash equivalents versus $209.4 million at March 31, 2021. Based on our 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 June 30, 2021, will enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements through 2023. This cash guidance is subject to a number of assumptions including those related to the severity and duration of the COVID-19 pandemic, the revenues, expenses and reimbursement associated with DEXTENZA, and the pace of research and clinical development programs, among other aspects of the 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 3436758. An archive of the webcast will be available until November 9, 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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 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. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI 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 operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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.

         

    Condensed 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,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Revenue:

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    11,718

     

     

    $

    1,569

     

     

    $

    19,061

     

     

    $

    4,178

     

    Total revenue, net

     

     

    11,718

     

     

     

    1,569

     

     

     

    19,061

     

     

     

    4,178

     

    Costs and operating expenses:

     

     

     

     

     

     

     

     

    Cost of product revenue

     

     

    1,096

     

     

     

    134

     

     

     

    1,988

     

     

     

    953

     

    Research and development

     

     

    13,859

     

     

     

    8,021

     

     

     

    24,786

     

     

     

    14,119

     

    Selling and marketing

     

     

    8,391

     

     

     

    6,153

     

     

     

    16,477

     

     

     

    13,283

     

    General and administrative

     

     

    8,603

     

     

     

    5,145

     

     

     

    16,268

     

     

     

    10,321

     

    Total costs and operating expenses

     

     

    31,949

     

     

     

    19,453

     

     

     

    59,519

     

     

     

    38,676

     

    Loss from operations

     

     

    (20,231

    )

     

     

    (17,884

    )

     

     

    (40,458

    )

     

     

    (34,498

    )

    Other income (expense):

     

     

     

     

     

     

     

     

    Interest income

     

     

    8

     

     

     

    17

     

     

     

    20

     

     

     

    156

     

    Interest expense

     

     

    (1,655

    )

     

     

    (1,694

    )

     

     

    (3,335

    )

     

     

    (3,327

    )

    Change in fair value of derivative liability

     

     

    13,396

     

     

     

    (17,007

    )

     

     

    38,412

     

     

     

    (20,411

    )

    Other income (expense), net

     

     

    1

     

     

     

     

     

     

    1

     

     

     

     

    Total other income (expense), net

     

     

    11,750

     

     

     

    (18,684

    )

     

     

    35,098

     

     

     

    (23,582

    )

    Net loss

     

    $

    (8,481

    )

     

    $

    (36,568

    )

     

    $

    (5,360

    )

     

    $

    (58,080

    )

    Net loss per share, basic

     

    $

    (0.11

    )

     

    $

    (0.64

    )

     

    $

    (0.07

    )

     

    $

    (1.06

    )

    Weighted average common shares outstanding, basic

     

     

    76,324,367

     

     

     

    57,368,292

     

     

     

    76,198,384

     

     

     

    54,634,572

     

    Net loss per share, diluted

     

    $

    (0.25

    )

     

    $

    (0.64

    )

     

    $

    (0.51

    )

     

    $

    (1.06

    )

    Weighted average common shares outstanding, diluted

     

     

    82,093,599

     

     

     

    57,368,292

     

     

     

    81,967,616

     

     

     

    54,634,572

     

     

    Ocular Therapeutix, Inc.

        

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     

     

     

     

     

     

     

    June 30,

     

    December 31,

     

     

    2021

     

    2020

    Assets

     

     

     

     

    Current assets:

     

     

     

     

    Cash and cash equivalents

     

    $

    191,860

     

     

    $

    228,057

     

    Accounts receivable, net

     

     

    18,734

     

     

     

    12,252

     

    Inventory

     

     

    1,112

     

     

     

    1,201

     

    Prepaid expenses and other current assets

     

     

    4,817

     

     

     

    4,650

     

    Total current assets

     

     

    216,523

     

     

     

    246,160

     

    Property and equipment, net

     

     

    7,042

     

     

     

    8,095

     

    Restricted cash

     

     

    1,764

     

     

     

    1,764

     

    Operating lease assets

     

     

    5,378

     

     

     

    5,844

     

    Total assets

     

    $

    230,707

     

     

    $

    261,863

     

    Liabilities and Stockholders' Equity

     

     

     

     

    Current liabilities:

     

     

     

     

    Accounts payable

     

    $

    3,881

     

     

    $

    2,709

     

    Accrued expenses and other current liabilities

     

     

    16,182

     

     

     

    14,307

     

    Operating lease liabilities

     

     

    1,487

     

     

     

    1,358

     

    Notes payable, net of discount, current

     

     

     

     

     

    8,290

     

    Total current liabilities

     

     

    21,550

     

     

     

    26,664

     

    Other liabilities:

     

     

     

     

    Operating lease liabilities, net of current portion

     

     

    6,770

     

     

     

    7,548

     

    Derivative liability

     

     

    59,901

     

     

     

    98,313

     

    Deferred revenue

     

     

    12,000

     

     

     

    12,000

     

    Notes payable, net of discount

     

     

    24,891

     

     

     

    16,936

     

    2026 convertible notes, net

     

     

    25,348

     

     

     

    24,307

     

    Total liabilities

     

     

    150,460

     

     

     

    185,768

     

    Commitments and contingencies

     

     

     

     

    Stockholders' equity:

     

     

     

     

    Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2021 and December 31, 2020, respectively

     

     

     

     

     

     

    Common stock, $0.0001 par value; 200,000,000 shares authorized and 76,454,597 and 75,996,732 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

     

     

    8

     

     

     

    8

     

    Additional paid-in capital

     

     

    624,850

     

     

     

    615,338

     

    Accumulated deficit

     

     

    (544,611

    )

     

     

    (539,251

    )

    Total stockholders' equity

     

     

    80,247

     

     

     

    76,095

     

    Total liabilities and stockholders' equity

     

    $

    230,707

     

     

    $

    261,863

     

     

     

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  6. Ocular plans to Continue its Efforts to Explore Innovative Anti-VEGF Agents

    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 Regeneron has terminated the option and license agreement collaboration between the companies. The termination became effective August 5, 2021.

    The collaboration with Regeneron was initially formed in 2016 for the development and commercialization of products containing the Company's sustained-release hydrogel technology in combination with Regeneron's large molecule vascular endothelial growth factor ("VEGF")-targeting compounds to address conditions…

    Ocular plans to Continue its Efforts to Explore Innovative Anti-VEGF Agents

    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 Regeneron has terminated the option and license agreement collaboration between the companies. The termination became effective August 5, 2021.

    The collaboration with Regeneron was initially formed in 2016 for the development and commercialization of products containing the Company's sustained-release hydrogel technology in combination with Regeneron's large molecule vascular endothelial growth factor ("VEGF")-targeting compounds to address conditions of the eye. Under a 2020 amendment, the Company and Regeneron's efforts have focused on research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space for the treatment of retinal diseases.

    "While we are sorry to see the collaboration end, we are very grateful for having had the chance to work with a company like Regeneron and a molecule like aflibercept," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Most importantly, we learned a great deal about how to formulate our proprietary hydrogel with monoclonal antibodies and to administer them to the suprachoroidal space. This work could become a valuable strategic driver for our future pipeline. We emerge from this collaboration with even more confidence in the versatility of our hydrogel platform and its utility in a route of administration which could become a safe and effective way to delivery medicine to the back of the eye."

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021, for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI 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 Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's ability to enter into and perform its obligations under its collaborations and the performance of its collaborators under such collaborations, 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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. First Clinical Trial to Assess a Single OTX-TKI Implant Containing a 600ug 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 patient in the United States Phase 1 clinical trial of OTX-TKI (axitinib intravitreal implant) for the treatment of wet age-related macular degeneration (wet AMD).

    "We are very excited to have recently begun dosing patients in this U.S. trial," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "The start of this trial is significant as this will be the first clinical trial…

    First Clinical Trial to Assess a Single OTX-TKI Implant Containing a 600ug 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 patient in the United States Phase 1 clinical trial of OTX-TKI (axitinib intravitreal implant) for the treatment of wet age-related macular degeneration (wet AMD).

    "We are very excited to have recently begun dosing patients in this U.S. trial," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "The start of this trial is significant as this will be the first clinical trial that will dose subjects with our single, higher dose, 600 µg implant. While current anti-VEGF treatments are effective, their durability is limited. OTX-TKI has the potential to be a new sustained release administration with 6 months or longer durability and a new mechanism of action for the treatment of patients with wet AMD and other retinal diseases. Based on early data from our Australian Phase 1 clinical trial, OTX-TKI has initially demonstrated acceptable tolerability, preliminary biological activity in some patients and durability for up to six months or longer in some cases."

    The Phase 1 clinical trial in the U.S. is a prospective, randomized, controlled, multi-center trial evaluating a single OTX-TKI implant containing a 600 µg dose of axitinib, compared with a 2 mg dose of aflibercept administered every eight weeks in subjects previously treated with anti-VEGF therapy. This trial is designed to assess the safety, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. The U.S.-based clinical trial of OTX-TKI is being conducted under an exploratory IND (eIND) application at five sites with a total of 20 randomized subjects: 15 subjects being treated with a single OTX-TKI implant containing 600 µg dose of axitinib in combination with an anti-VEGF induction injection, and 5 subjects being treated at eight-week intervals with a dose of aflibercept.

    About Age-Related Macular Degeneration

    AMD, a progressive retinal disease that is the leading cause of blindness in adults over the age of 60, is estimated to affect approximately 11 to 15 million people in the U.S. AMD affects the center portion of the retina, called the macula, which is responsible for central vision and color perception. There are two forms of AMD; the dry form, which affects between 85-90% of patients, and the wet form, an aggressive form of AMD which affects the remaining 10-15% of patients. In patients with wet AMD, abnormal blood vessels grow underneath and into the retina. These abnormal blood vessels leak fluid and blood into and beneath the retina, causing vision loss.

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021, for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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 and other Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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 it will report second quarter financial results on Monday, August 9, 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…

    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 financial results on Monday, August 9, 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 3436758. An archive of the webcast will be available until November 9, 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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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.

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  9. 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 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held July 23-27, 2021 in Las Vegas, NV.

    "At ASCRS, we will be presenting data on multiple programs we are advancing in the clinic as well as DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use which is commercially available to treat post-operative ocular inflammation and pain and ReSure® Sealant, an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery…

    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 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held July 23-27, 2021 in Las Vegas, NV.

    "At ASCRS, we will be presenting data on multiple programs we are advancing in the clinic as well as DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use which is commercially available to treat post-operative ocular inflammation and pain and ReSure® Sealant, an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery," commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "The data being presented continue to support the use of DEXTENZA to treat post-operative ocular inflammation and pain and the ability to research the use of our proprietary hydrogel technology to potentially meet the unmet needs in the ophthalmic space, specifically in glaucoma, dry eye disease and allergic conjunctivitis. As we continue to advance and expand our pipeline, we are pleased with the results we are seeing in both the clinic and surgical settings and continue to evaluate the potential ways to best expand our versatile pipeline."

    Ocular Therapeutix Presentations at ASCRS:

    DEXTENZA® (Post-operative Ocular Inflammation and Pain):

    • Title: Real World Early Physician Experience Using an Intracanalicular Dexamethasone Insert to Treat Post-Operative Ocular Inflammation and Pain

    Session Title: Medications (Preoperative, Postoperative, Intraoperative)

    Session Date/Times: Monday, July 26, 2021 at 10:45 AM-10:50 AM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: John D Stephens, MD

    ASCRS Paper ID: 76462

    • Title: Real World Time Savings on Patient Education and Call Backs Related to Post Cataract Therapy Using an Intracanalicular Dexamethasone Insert

    Session Title: Medications (Preoperative, Postoperative, Intraoperative)

    Session Date/Times: Monday, July 26, 2021 at 10:55 AM-11:00 AM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Cynthia Matossian, MD

    ASCRS Paper ID: 76483

    OTX-DP (dexamethasone ophthalmic insert, 0.4 mg) (Allergic Conjunctivitis):

    • Title: Physician Impressions on Real World Use of Topical Corticosteroids for the Treatment of Allergic Conjunctivitis: Need for a Safer Steroid

    Session Title: Ocular Surface II

    Session Date/Times: Sunday, July 25, 2021 at 1:40 PM-1:45 PM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Lisa Nijm, JD, MD, ABO

    ASCRS Paper ID: 76511

    • Title: Pooled Analysis Evaluating Efficacy and Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis

    Session Title: Ocular Surface II

    Session Date/Times: Sunday, July 25, 2021 at 1:45 PM-1:50 PM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Jay M Rubin, MD

    ASCRS Paper ID: 76531

    Pipeline:

    • Title: Safety and Efficacy of a Novel, Hydrogel-Based Cyclosporine Intracanalicular Insert, for the Treatment of Dry Eye Disease - Phase 1 Study

    Session Title: Ocular Surface II

    Session Date/Times: Sunday, July 25, 2021 at 1:35 PM-1:40 PM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Lee Shettle, DO

    ASCRS Paper ID: 76276

    • Title: Evaluating Safety, Tolerability & Efficacy of a Hydrogel-Based Intracameral Travoprost Implant in Glaucoma Patients: Phase 1 Interim Analyses

    Session Title: Glaucoma - Medications

    Session Date/Times: Sunday, July 25, 2021 at 2:30 PM-2:35 PM PT

    Location: MBCR – Level 2, Lagoon F

    Presenter: Thomas Walters, MD

    ASCRS Paper ID: 76727

    ReSure® Sealant:

    • Title: Retrospective Study Comparing the Incidence of Endophthalmitis Following Cataract Surgery in Practices with Access to Hydrogel Sealant

    Session Title: Surgical Comparisons

    Session Date/Times: Sunday, July 25, 2021 at 8:30 AM-8:35 AM PT

    Location: MBCR – Level 2, Surf CD

    Presenter: Leon Herndon, MD

    Other:

    • Title: Incidence of Endophthalmitis Following Cataract Surgery and Risk Factors: Retrospective Study Using the IRIS Registry

    Session Title: Surgical Outcomes

    Session Date/Times: Sunday, July 25, 2021 at 8:32 AM-8:37 AM PT

    Location: MBCR – Level 2, Surf EF

    Presenter: Michael H Goldstein, MD

    ASCRS Paper ID: 76786

    Investigator-Initiated Trials Presented at ASCRS:

    • Title: The Restore Study: Safety and Efficacy of DEXTENZA for Post-Operative Inflammation and Pain Following PRK

    Session Title: Refractive Outcomes

    Session Date/Times: Sunday, July 25, 2021 at 8:15 AM-8:20 AM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Brian M Shafer, MD

    • Title: Intracanalicular Dexamethasone Insert for Post-Corneal Crosslinking Inflammation and Pain

    Session Title: Crosslinking/Corneal Infectious Diseases

    Session Date/Times: Sunday, July 25, 2021 at 1:30 PM-1:32 PM PT

    Location: MBCR – Level 2, Surf EF

    Presenter: Eric D Rosenberg, DO, MSE

    • Title: A Retrospective Analysis of Outcomes Using an Intracanalicular Dexamethasone Implant in Post Cataract and/or Cataract-MIGS Surgery Patients

    Session Title: Glaucoma- Medications

    Session Date/Times: Sunday, July 25, 2021 at 2:35 PM-2:40 PM PT

    Location: MBCR – Level 2, Lagoon F

    Presenter: Inder P Singh, MD

    • Title: Immediate Postoperative Versus Next-Day Dexamethasone Intracanalicular Insert for Inflammation and Pain Control Following Cataract Surgery

    Session Title: Medications (Preoperative, Postoperative, Intraoperative)

    Session Date/Times: Monday, July 26, 2021 at 10:10 AM-10:15 AM PT

    Location: MBCR – Level 2, Surf AB

    Presenter: Brian B Foster, MD, ABO

    • Title: Postoperative Symptom Control with an Intracanalicular Dexamethasone Insert Compared to Topical Steroid Drops Following Pterygium Surgery

    Cornea Posters available On-Demand

    Presenter: Haroon Ilyas, MD

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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 and other Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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. Company Anticipates Record Quarter for In-Market DEXTENZA Sales

    Second Quarter 2021 Net Product Revenue Up Approximately 60% and In-Market Unit Volumes Up Approximately 50% Sequentially Over the First Quarter of 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 reported preliminary net product revenue for the quarter ended June 30, 2021, and in-market unit sales for June 2021.

    The Company is reporting preliminary second quarter 2021 total net product revenue of approximately $11.7 million, representing a greater than 600% year-over-year increase versus the second quarter 2020 and an approximately…

    Company Anticipates Record Quarter for In-Market DEXTENZA Sales

    Second Quarter 2021 Net Product Revenue Up Approximately 60% and In-Market Unit Volumes Up Approximately 50% Sequentially Over the First Quarter of 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 reported preliminary net product revenue for the quarter ended June 30, 2021, and in-market unit sales for June 2021.

    The Company is reporting preliminary second quarter 2021 total net product revenue of approximately $11.7 million, representing a greater than 600% year-over-year increase versus the second quarter 2020 and an approximately 60% sequential increase over the first quarter of 2021. Net product revenue of DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg for the quarter ended June 30, 2021 is estimated to be $11.1 million, and net product revenue of ReSure® Sealant for the quarter ended June 30, 2021 is estimated to be $0.6 million.

    DEXTENZA second quarter, in-market unit sales are projected to set a record of 24,990 billable inserts, an approximately 50% sequential increase over the first quarter of 2021. The Company believes this growth reflects the strong end-user demand for DEXTENZA driven by an increase in cataract procedure volumes and market share gains. June 2021 in-market unit sales are projected to set a monthly record of 9,779 billable inserts as cataract volumes continued to increase through the second quarter of 2021 after the slowing of procedures earlier in the year as a result of regional COVID surges. As previously reported, April and May in-market unit sales were 8,025 and 7,186 billable inserts, respectively. Notably, each month of the second quarter of 2021 exceeded the last month of the first quarter of 2021, which included increased end-of-the-quarter in-market unit sales to ambulatory surgical centers under the Company's rebate program.

    "We are pleased by DEXTENZA's performance in the quarter and believe that continued physician interest and more normalized cataract procedure volumes bode well for strong growth through the remainder of the year," said Antony Mattessich, President and CEO. "What gives us the greatest satisfaction however is knowing that more and more patients are enjoying a better experience following their ophthalmic surgeries."

    The Company expects to report quarterly financial results for the second quarter 2021 on August 9th following the close of market and provide a comprehensive business update on a conference call the same day.

    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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication 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-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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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 and other Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 preclinical and 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 and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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, entered into a discovery collaboration with Mosaic Biosciences to identify new targets and therapeutic agents aimed at the treatment of Dry Age-related Macular Degeneration (dAMD).

    Under terms of the agreement, the collaboration between Ocular Therapeutix and Mosaic focuses on the discovery and development of novel complement inhibitors with extended duration of activity. The complement pathway represents a key component of innate immunity and maintains immune homeostasis throughout the body, including ocular tissues. Within the retina, the complement…

    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, entered into a discovery collaboration with Mosaic Biosciences to identify new targets and therapeutic agents aimed at the treatment of Dry Age-related Macular Degeneration (dAMD).

    Under terms of the agreement, the collaboration between Ocular Therapeutix and Mosaic focuses on the discovery and development of novel complement inhibitors with extended duration of activity. The complement pathway represents a key component of innate immunity and maintains immune homeostasis throughout the body, including ocular tissues. Within the retina, the complement pathway has been associated with the development of age-related macular degeneration. The goal of complement inhibition is to block the pathway that can initiate and drive these diseases.

    "This agreement with Mosaic Biosciences marks an important step forward for our company and how we approach the discovery and development of ophthalmic products," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Historically, our products have been developed by combining a known active pharmaceutical ingredient (API) with our proprietary hydrogel technology to create innovate treatments for diseases of the eye. However, certain diseases are very challenging to treat with existing agents. Working with Mosaic, we hope to incorporate the discovery of new chemical entities into our current drug development approach and to identify novel, sustained release products to expand our innovative ophthalmic portfolio."

    "We are pleased to begin working with Ocular, one of the leading ophthalmology companies in the industry," commented Eric Furfine, Co-Chief Executive Officer and Chief Scientific Officer of Mosaic Biosciences. "At Mosaic we are focused on leveraging our expertise in research and proprietary protein engineering to discover novel compounds. Based on our extensive working knowledge of the complement pathway, along with Ocular's expertise in sustained release technology, we look forward to discovering and developing novel compounds to treat a debilitating disease like dAMD."

    Under the terms of the agreement, Ocular Therapeutix has agreed to fund the research performed under the collaboration and retains all program inventions and associated intellectual property.

    About Age-Related Macular Degeneration

    AMD, a progressive retinal disease that is the leading cause of blindness in adults over the age of 60, is estimated to affect approximately 11 to 15 million people in the U.S. AMD affects the center portion of the retina, called the macula, which is responsible for central vision and color perception. There are two forms of AMD; the dry form which affects between 85-90% of patients and the wet form which affects the remaining 10-15% of patients. The dry form of AMD features slowly progressive, degenerative changes in the retinal pigment epithelial cells, Bruch's membrane, and the choroid (the area beneath the retina) that over time leads to a thinning of the macula, causing the macula to lose its function. As dry AMD progresses, it leads to an irreversible degeneration of retinal cells that results in permanent loss of vision. The disease and resulting vision loss is a major contributor to loss of independence and diminished quality of life in older persons. Although there are FDA-approved treatments for wet AMD, there are no treatments currently approved by the FDA for the dry form of AMD.

    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 received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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.

    About Mosaic Biosciences, Inc.

    Mosaic Biosciences is a private biotechnology company focused on helping partners discover and develop novel protein therapeutics. Mosaic's partners range from early-stage start-ups to development-stage companies. Mosaic's approach leverages proprietary and public domain technologies to invent best-in-class antibody and other protein therapeutics, and to advance them into preclinical development. Mosaic's team provides experienced pharmaceutical scientists, and the leadership and vision to drive and coordinate internal and external resources. Based on each partner's needs, Mosaic offers the ability to execute any part or all of a program. Mosaic's goals are its partners' goals.

    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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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 and other Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational 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 preclinical and 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, conduct and outcomes 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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 participate at the following conferences:

    Jefferies Virtual Healthcare Conference
    Date: Tuesday, June 1, 2021
    Analyst-hosted fireside chat: 4:00 PM ET

    The JMP Securities Life Sciences Conference
    Date: Wednesday, June 16, 2021
    Analyst-hosted fireside chat: 12:00 PM ET

    Raymond James Healthcare Conference 2021
    Date: Wednesday, June 23, 2021
    New Treatments for Dry Eye Panel: 1:20 PM 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…

    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:

    Jefferies Virtual Healthcare Conference

    Date: Tuesday, June 1, 2021

    Analyst-hosted fireside chat: 4:00 PM ET

    The JMP Securities Life Sciences Conference

    Date: Wednesday, June 16, 2021

    Analyst-hosted fireside chat: 12:00 PM ET

    Raymond James Healthcare Conference 2021

    Date: Wednesday, June 23, 2021

    New Treatments for Dry Eye Panel: 1:20 PM 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 Jefferies, JMP Securities or Raymond James representative.

    A live webcast of the fireside chats during the Jefferies Virtual Healthcare Conference and The JMP Securities 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 received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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.

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  13. DEXTENZA® Achieved Quarterly Record of 16,634 Billable Units Sold to End Customers, Representing Quarterly Sequential Growth of 15%.

    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 financial results for the first quarter of 2021, and provided updates on its strong ophthalmology pipeline.

    "Our progress in the first quarter of 2021 was significant," said Antony Mattessich, President and Chief Executive Officer. "Revenue for DEXTENZA® was up over 200% against the prior year period and we achieved record quarterly, in-market sales in excess of 16,000 billable units, representing 15…

    DEXTENZA® Achieved Quarterly Record of 16,634 Billable Units Sold to End Customers, Representing Quarterly Sequential Growth of 15%.

    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 financial results for the first quarter of 2021, and provided updates on its strong ophthalmology pipeline.

    "Our progress in the first quarter of 2021 was significant," said Antony Mattessich, President and Chief Executive Officer. "Revenue for DEXTENZA® was up over 200% against the prior year period and we achieved record quarterly, in-market sales in excess of 16,000 billable units, representing 15% sequential quarterly growth. Encouragingly, the momentum we saw in the first quarter has continued into the second quarter with estimated sales in excess of 8,000 billable units in April alone. Beyond DEXTENZA, we have made progress in advancing our pipeline of product candidates that continue to show potential to set the standard of care in their respective disease areas. We have had a large presence at this year's ongoing ARVO meeting with seven total presentations highlighting both pre-clinical and clinical updates in our key programs. In 2021 we look forward to continued momentum with DEXTENZA and further development of our pipeline which includes the planned initiation of two Phase 2 programs in wet-AMD and glaucoma and the expected completion of a Phase 2 clinical trial in dry eye disease."

    Recent Business Updates

    Presented Pre-Clinical and Clinical Data at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Six company presentations and one presentation from an investigator-initiated trial are being held at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Meeting this week. Updated interim analyses of Phase 1 data for both OTX-TKI for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases and OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension were presented. Both presentations provided additional data that continue to support the development of products that could become the standard of care in these large markets.

    Data are also being presented on the Company's products targeting ocular surface disease including pre-clinical pharmacokinetic data on OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of signs and symptoms of dry eye disease. Additionally, we are presenting a post-hoc analysis of data on DEXTENZA® (dexamethasone ophthalmic insert) for the treatment of allergic conjunctivitis. The use of DEXTENZA in allergic conjunctivitis is currently under U.S. Food and Drug Administration (FDA) review with a target action Prescription Drug User Fee Act (PDUFA) date of October 18, 2021. This presentation evaluates the safety of the product candidate across the four clinical trials conducted.

    U.S. Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA® for the quarter was $6.7 million, an approximately 220% increase over the first quarter of 2020. Net sales for the quarter were flat relative to the previous quarter primarily due to variations in distributor inventory levels. DEXTENZA in-market unit volume to surgery centers, which is the best determinant of true underlying demand, achieved a record in the first quarter of 16,634 billable inserts and grew at approximately 15% sequentially over the previous quarter. As previously reported, January and February in-market billable inserts were 4,582 and 4,901, respectively. In-market demand then rebounded strongly in March with sales of billable inserts achieving a record month of 7,151 units.

    The Company is also reporting that April in-market, billable units are estimated to have exceeded 8,000 units, setting a new monthly record.

    Dosed First Patient in Phase 2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical trial is a U.S.-based, prospective, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations of a new dexamethasone drug product candidate OTX-DED in approximately 150 subjects with dry eye disease. Subjects are to be followed for approximately two months after randomization. This trial is designed to assess the safety and efficacy of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, the visual analog score of eye dryness and severity, and total corneal fluorescein staining.

    Key Program Updates

    • OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet AMD and other retinal diseases.
      • The Company filed an exploratory IND (eIND) in November 2020 to initiate a Phase 1 clinical trial of OTX-TKI in the United States. A planned U.S.-based Phase 1 clinical trial is anticipated to start in mid-2021.
    • OTX-TIC (travoprost intracameral implant) for the treatment of patients with primary open-angle glaucoma or ocular hypertension.
      • The Company completed enrollment of all four cohorts of its Phase 1 clinical trial.
      • The Company plans to initiate a randomized, double-masked, active-controlled Phase 2 clinical trial in the fourth quarter of 2021 in the United States with a total of approximately 105 subjects to evaluate two different formulations of OTX-TIC versus a control arm receiving Durysta™.
    • OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease.
      • The Company has completed enrollment of a U.S.-based Phase 2, randomized, double-masked, multi-center clinical trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus hydrogel vehicle insert.
      • Top-line data from the Phase 2 clinical trial are expected in the fourth quarter of 2021.
    • OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease.
      • The Company dosed the first subject in a U.S.-based, prospective, randomized, double-masked, vehicle-controlled, multi-center Phase 2 clinical trial in approximately 150 subjects with dry eye disease.
      • Data from the Phase 2 clinical trial is expected in the first half of 2022.
    • DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular itching associated with allergic conjunctivitis.
      • The FDA has set a target action PDUFA date of October 18, 2021.
    • ReSure® Sealant is designed to prevent wound leaks in corneal incisions following cataract surgery.
      • The Company has received notification from FDA confirming that the Company has fulfilled all post-approval study requirements for ReSure® Sealant, with a requirement to update the ReSure label reflecting the study results.

    First Quarter Ended March 31, 2021 Financial Results

    Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $7.3 million for the three months ended March 31, 2021, representing a greater than 175% increase over the first quarter of 2020. Net product revenue of DEXTENZA® in the first quarter was $6.7 million versus $2.1 million in the comparable quarter 2020 and reflects an approximate 220% increase. Total net product revenue for the first quarter of 2021 also includes net product revenue of $0.6 million from ReSure® Sealant.

    Research and development expenses for the first quarter of 2021 were $10.9 million versus $6.1 million for the comparable period in 2020 primarily driven by increased headcount as well as increased clinical trial costs associated with the ongoing Phase 2 clinical trial for OTX-CSI, the commencement of the Phase 2 clinical trial of OTX-DED and the ongoing Phase 1 clinical trials of OTX-TKI and OTX-TIC.

    Selling and marketing expenses in the first quarter of 2021 were $8.1 million as compared to $7.1 million for the same quarter in 2020, primarily reflecting increased personnel costs associated with expansion of the sales force.

    General and administrative expenses were $7.7 million for the first quarter of 2021 versus $5.2 million in the comparable quarter of 2020. The increase in expenses stemmed primarily from increased personnel expenses and professional fees.

    The Company reported net income of $3.1 million, or a profit of $0.04 per share on a basic basis and a net loss of $(20.8) million, or a loss of $(0.24) per share on a diluted basis in the first quarter of 2021. This compares to a net loss of $(21.5) million, or a loss of $(0.41) per share on a basic and diluted basis for the same period in 2020. As operating expenses increased quarter over quarter, the modest profit was driven by a non-cash gain of $25.0 million related to the change in the fair value of the derivative liability associated with the Company's convertible notes. This change in fair value was due primarily to a decline in the Company's common stock price during the first quarter of 2021. Non-cash charges for stock-based compensation and depreciation and amortization were $3.7 million in the first quarter of 2021 versus $2.4 million for the same quarter in 2020.

    As of May 1, 2021, the Company had 76.3 million shares outstanding.

    As of March 31, 2021, the Company had $209.4 million in cash and cash equivalents versus $228.1 million at December 31, 2020. 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 March 31, 2021, will enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements through 2023. This cash guidance is subject to a number of assumptions including those related to the severity and duration of the COVID-19 pandemic, the revenues and expenses associated with the commercialization of DEXTENZA, and the pace of research and clinical development programs, and other aspects of the 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 3944056. An archive of the webcast will be available until August 5, 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 received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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, in-market sales and other financial and operational 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, conduct and outcomes 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 in-market 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 severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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, whether as a result of new information, future events or otherwise, 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 March 31,

     

     

    2021

     

    2020

    Revenue:

     

     

     

     

     

     

    Product revenue, net

     

    $

    7,342

     

     

    $

    2,609

     

    Total revenue, net

     

     

    7,342

     

     

     

    2,609

     

    Costs and operating expenses:

     

     

     

     

     

     

    Cost of product revenue

     

     

    892

     

     

     

    819

     

    Research and development

     

     

    10,927

     

     

     

    6,098

     

    Selling and marketing

     

     

    8,086

     

     

     

    7,130

     

    General and administrative

     

     

    7,665

     

     

     

    5,176

     

    Total costs and operating expenses

     

     

    27,570

     

     

     

    19,223

     

    Loss from operations

     

     

    (20,228

    )

     

     

    (16,614

    )

    Other income (expense):

     

     

     

     

     

     

    Interest income

     

     

    12

     

     

     

    139

     

    Interest expense

     

     

    (1,679

    )

     

     

    (1,633

    )

    Change in fair value of derivative liability

     

     

    25,016

     

     

     

    (3,404

    )

    Total other income (expense), net

     

     

    23,349

     

     

     

    (4,898

    )

    Net income (loss) attributable to common stockholders

     

    $

    3,121

     

     

    $

    (21,512

    )

    Net income (loss) per share, basic

     

    $

    0.04

     

     

    $

    (0.41

    )

    Weighted average common shares outstanding, basic

     

     

    76,071,017

     

     

     

    51,900,882

     

    Net income (loss) per share, diluted

     

    $

    (0.24

    )

     

    $

    (0.41

    )

    Weighted average common shares outstanding, diluted

     

     

    87,245,706

     

     

     

    51,900,882

     

    OCULAR THERAPEUTIX, INC.

       

    Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (unaudited)

     

     

     

    March 31,

     

    December 31,

     

     

    2021

     

    2020

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    209,378

     

    $

    228,057

    Accounts receivable, net

     

     

    13,631

     

     

    12,252

    Inventory

     

     

    1,123

     

     

    1,201

    Prepaid expenses and other current assets

     

     

    4,000

     

     

    4,650

    Total current assets

     

     

    228,132

     

     

    246,160

    Property and equipment, net

     

     

    7,527

     

     

    8,095

    Restricted cash

     

     

    1,764

     

     

    1,764

    Operating lease assets

     

     

    5,617

     

     

    5,844

    Total assets

     

    $

    243,040

     

    $

    261,863

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    4,152

     

    $

    2,709

    Accrued expenses and other current liabilities

     

     

    13,574

     

     

    14,307

    Operating lease liabilities

     

     

    1,421

     

     

    1,358

    Notes payable, net of discount, current

     

     

    8,290

     

     

    8,290

    Total current liabilities

     

     

    27,437

     

     

    26,664

    Other liabilities:

     

     

     

     

     

     

    Operating lease liabilities, net of current portion

     

     

    7,169

     

     

    7,548

    Derivative liability

     

     

    73,297

     

     

    98,313

    Deferred revenue

     

     

    12,000

     

     

    12,000

    Notes payable, net of discount

     

     

    14,907

     

     

    16,936

    2026 convertible notes, net

     

     

    24,822

     

     

    24,307

    Total liabilities

     

     

    159,632

     

     

    185,768

    Commitments and contingencies

     

     

     

     

     

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

     

     

    Common stock, $0.0001 par value; 100,000,000 shares authorized and 76,236,710 and 75,996,732 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

    8

     

     

    8

    Additional paid-in capital

     

     

    619,530

     

     

    615,338

    Accumulated deficit

     

     

    (536,130)

     

     

    (539,251)

    Total stockholders' equity

     

     

    83,408

     

     

    76,095

    Total liabilities and stockholders' equity

     

    $

    243,040

     

    $

    261,863

     

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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, has received notification from the U.S. Food and Drug Administration (FDA) confirming it has fulfilled all post-approval study requirements for ReSure® Sealant, with a requirement to update the ReSure label reflecting the study results. As a condition for ReSure's pre-market approval application (PMA) in 2014, the FDA required two post-approval studies to be completed. The first, referred to as the Clinical Post-Approval Study, was completed in 2016. This notification marks the completion of the second, the Device Exposure Registry Study, a retrospective…

    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, has received notification from the U.S. Food and Drug Administration (FDA) confirming it has fulfilled all post-approval study requirements for ReSure® Sealant, with a requirement to update the ReSure label reflecting the study results. As a condition for ReSure's pre-market approval application (PMA) in 2014, the FDA required two post-approval studies to be completed. The first, referred to as the Clinical Post-Approval Study, was completed in 2016. This notification marks the completion of the second, the Device Exposure Registry Study, a retrospective analysis comparing endophthalmitis rates from sites that purchased ReSure Sealant versus sites that did not.

    "We are happy to have completed the FDA's post-approval requirements for our ReSure Sealant product" said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutics. "ReSure is well-regarded by anterior segment surgeons and this study only adds to the body of knowledge supporting its use."

    This retrospective study evaluated endophthalmitis rates at sites with access to ReSure compared with the rate at sites without access to ReSure using the American Academy of Ophthalmology's IRIS® Registry (Intelligent Research in Sight) database. In total, 6.7 million eyes that underwent cataract surgery with insertion of an intraocular lens between January 2016 and December 2019 were evaluated in the study. The endophthalmitis rates for sites with access to ReSure was 0.609 per 1,000 surgeries, compared with 0.660 per 1,000 surgeries for sites without access to ReSure (p=0.01). Overall, the results of the study demonstrated there was no clinically or statistically significant difference in the incidence of endophthalmitis within 30 days of any cataract surgery between cohorts with and without access to ReSure Sealant.

    Ocular plans to submit a PMA supplement to modify the existing ReSure label to reflect the findings from the recently completed study.

    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 has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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 and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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, 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, conduct and outcomes 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 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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  15. 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 2021 Annual Meeting being moved to a virtual format, video-recorded presentations are scheduled to become available online at ARVOLearn on May 1, 2021.

    "We are pleased to be presenting data on our pre-clinical and clinical programs at this year's annual meeting, including updated data on two of our key programs, OTX-TKI for the treatment of wet AMD and OTX-TIC for the reduction of intraocular pressure in patients…

    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 2021 Annual Meeting being moved to a virtual format, video-recorded presentations are scheduled to become available online at ARVOLearn on May 1, 2021.

    "We are pleased to be presenting data on our pre-clinical and clinical programs at this year's annual meeting, including updated data on two of our key programs, OTX-TKI for the treatment of wet AMD and OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension," commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "The progress we are making in these two programs is exciting as we look to advance each into Phase 2 clinical trials. Our hydrogel platform continues to offer patients and physicians a potential 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:

    • Title: Safety and Efficacy of Topical, Transzonular, and Intracanalicular Corticosteroids for the Prevention of Postoperative Inflammation after Cataract Surgery

      Session Title: Cataract Surgery/Epidemiology

      Session Date/Times: May 2, 2021 from 11:15 AM to 1:00 PM EDT

      Presenter: Dr. Amy Lu
    • Title: Phase 1 Study of an Intracameral Travoprost Hydrogel-based Implant for the Treatment of POAG and Ocular Hypertension

      Session Title: Pharmacological intervention and cellular mechanisms

      Session Date/Times: May 3, 2021 from 11:15 AM to 1:00 PM EDT

      Presenter: Dr. Damien Goldberg
    • Title: Incidence of Endophthalmitis Following Routine or Complex Cataract Surgery in Practices With and Without Access to Hydrogel Sealant: Retrospective Study Using the IRIS Registry

      Session Title: Healthcare Delivery and Quality of Care

      Session Date/Times: May 5, 2021 from 9:00 AM to 10:45 AM EDT

      Presenter: Dr. Michael H Goldstein
    • Title: Phase 1 Study of an Intravitreal Axitinib Hydrogel-based Implant for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

      Session Title: AMD and retinal physiology

      Session Date/Times: May 5, 2021 from 2:45 PM to 4:30 PM EDT

      Presenter: Dr. James Wong
    • Title: Ocular Pharmacokinetics of OTX-DED, a Sustained-release Intracanalicular Insert Delivering Dexamethasone, in a Canine Model

      Session Title: Dry Eye and Tear film

      Session Date/Times: May 5, 2021 from 2:45 PM to 4:30 PM EDT

      Presenter: Charles Blizzard
    • Title: Pharmacokinetics of OTX-CSI, a Cyclosporine Intracanalicular Insert, in Surgically Induced Dry Eye Beagle Dogs

      Session Title: Cornea, cytokines, anti-inflammatory

      Session Date/Times: May 7, 2021 from 2:15 PM to 4:00 PM EDT

      Presenter: Andrew Vanslette
    • Title: Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post-hoc Analysis of Four Studies

      Session Title: Cornea, cytokines, anti-inflammatory

      Session Date/Times: May 7, 2021 from 2:15 PM to 4:00 PM EDT

      Presenter: Dr. John Meyer

    The online presentations are expected to 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®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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 presentations at medical, scientific or industry 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 the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms 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, 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, conduct and outcomes 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 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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  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 it will report first quarter financial results on Wednesday, May 5, 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…

    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 financial results on Wednesday, May 5, 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 3944056. An archive of the webcast will be available until August 5, 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 received a PDUFA target action date of October 18, 2021, for an sNDA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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.

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  17. 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 financial results for the fourth quarter and year ended December 31, 2020 and provided updates on its leading ophthalmology pipeline.

    "The fourth quarter marked considerable commercial, clinical and regulatory progress for the Company," said Antony Mattessich, President and Chief Executive Officer. "Physician interest in DEXTENZA® remains high, and despite the challenging backdrop of COVID, adoption by ASCs and HOPDs continues to drive strong growth in reported sales. In the fourth quarter of 2020, in-market purchases were in excess…

    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 financial results for the fourth quarter and year ended December 31, 2020 and provided updates on its leading ophthalmology pipeline.

    "The fourth quarter marked considerable commercial, clinical and regulatory progress for the Company," said Antony Mattessich, President and Chief Executive Officer. "Physician interest in DEXTENZA® remains high, and despite the challenging backdrop of COVID, adoption by ASCs and HOPDs continues to drive strong growth in reported sales. In the fourth quarter of 2020, in-market purchases were in excess of 14,000 billable units, representing sequential quarterly growth of greater than 40%. Beyond DEXTENZA, we have a unique pipeline of ophthalmology product candidates that each target indications within multi-billion dollar segments of the ophthalmology market. In 2021 we look forward to initiating multiple Phase 2 programs."

    Recent Business Updates

    Presented Interim Data from the Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) in Patients with Wet Age-Related Macular Degeneration (wet AMD) at Angiogenesis, Exudation, and Degeneration 2021. Interim data from the Phase 1 clinical trial continued to support that the product candidate has been generally well tolerated and observed to have a favorable safety profile, shows preliminary biological activity with a decrease in retinal fluid observed by two months in some subjects in cohorts 2 and 3 and initial durability in several subjects in cohort 2 over six months and in one subject over 13 months. The presentation can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    Presented Interim Data from the Phase 1 Clinical Trial of OTX-TIC (travoprost intracameral implant) in Patients with Primary Open Angle Glaucoma or Ocular Hypertension at the 10th Annual Glaucoma 360 New Horizons Forum. Interim data from the Phase 1 clinical trial from the four fully enrolled cohorts generally showed a mean reduction in intraocular pressure from baseline of 7-11 mm Hg with onset of action as early as two days after insertion and sustained durability of activity of six months or longer with a single implant in many subjects. Overall, no serious ocular adverse events were noted. The presentation can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com.

    Dosed First Patient in Phase 2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations of a new dexamethasone drug product candidate OTX-DED (dexamethasone intracanalicular insert) in approximately 150 subjects with dry eye disease. In accordance with the clinical trial protocol, the subjects are to be followed for approximately two months after randomization. This trial is designed to assess the safety and efficacy of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, eye dryness score/frequency of eye dryness using visual analog scale, and total corneal fluorescein staining.

    U.S. Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg for the quarter was $6.9 million, a 28% sequential increase over the third quarter of 2020. The Company believes the record quarter of DEXTENZA sales was driven by continued increases in surgical volumes, new account growth, the positive impact of the DEXTENZA rebate program and greater awareness by physicians of procedure reimbursement. Further building on the reimbursement, in November the American Medical Association announced its intention to establish a permanent Category 1 Current Procedure Terminology (CPT) Code, effective January 1, 2022, for the administration of drug-eluting intracanalicular inserts, including DEXTENZA.

    Notified of target PDUFA date for DEXTENZA allergic conjunctivitis sNDA. On March 4th, the Company announced the supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of October 18, 2021.

    Promoted Michael Goldstein, MD, MBA, to President, Ophthalmology and Appointed Rabia Gurses-Ozden, MD as Senior Vice President, Clinical Development. Following his promotion, Dr. Goldstein is maintaining his role as Chief Medical Officer while adding responsibilities for commercial operations in alignment with the overall Company strategy. Dr. Ozden has become 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 reflect Ocular's commitment to developing innovative therapies for diseases and conditions of the eye and are expected to play a key role in supporting Ocular's potential growth.

    Received $12 Million Initial Upfront Payment from Recently Signed AffaMed Collaboration. In October, the Company entered into a licensing agreement with AffaMed Therapeutics for rights to develop and commercialize DEXTENZA and OTX-TIC in greater China, South Korea and the ASEAN markets. Beyond the $12 million in upfront payments, the Company has the potential to receive up to an additional $91 million in future aggregate milestones and payments and to receive tiered double-digit royalties on future sales.

    Raised an Additional $86.3 Million in Net Proceeds from Equity Offering. In December, the Company raised $86.3 million net in a follow-on equity offering at a public offering price of $21.50 per share. The Company had $228.1 million in cash and cash equivalents as of December 31, 2020.

    Key Program Updates

    • OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.
      • The Company filed an exploratory IND (eIND) and received clearance from the FDA to initiate a Phase 1 clinical trial of OTX-TKI in the United States. A planned U.S.-based Phase 1 clinical trial is anticipated to start in mid-2021 and to consist of 20 subjects: 15 dosed with 600 µg plus an anti-VEGF induction injection and 5 dosed with aflibercept every eight weeks.
    • OTX-TIC (travoprost intracameral implant) for the treatment of patients with primary open angle glaucoma or ocular hypertension.
      • The Company completed enrollment of all four cohorts of its Phase 1 clinical trial.
      • The Company plans to initiate a randomized, double-masked, active-controlled Phase 2 clinical trial in mid-2021 in the United States with a total of approximately 105 subjects to evaluate two different formulations of OTX-TIC versus a control arm receiving Durysta™.
    • OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease.
      • The Company 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 hydrogel vehicle insert in approximately 140 subjects for the chronic treatment of dry eye disease.
      • Enrollment in the Phase 2 study has progressed ahead of schedule and topline data is now expected in the fourth quarter of 2021 versus prior guidance of the first half of 2022.
    • OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease.
      • The Company dosed the first subject in U.S.-based, randomized, double-masked, vehicle-controlled, multi-center Phase 2 clinical trial in approximately 150 subjects with dry eye disease.
      • Data from the Phase 2 clinical trial is expected in the first half of 2022.

    Fourth Quarter and Year Ended December 31, 2020 Financial Results

    Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was approximately $7.4 million for the three months ended December 31, 2020, reflecting a 25% sequential increase over the third quarter and a 226% increase over the fourth quarter 2019. Net product revenue of DEXTENZA® in the fourth quarter 2020 was $6.9 million versus $5.4 million in the third quarter 2020 and reflects an approximate 28% sequential increase. Total net product revenue for the fourth quarter of 2020 also includes net product revenue of $0.5 million from ReSure® Sealant. Overall, net product revenue for the year was $17.4 million versus $4.2 million for 2019 and primarily reflects a strong uptake in DEXTENZA sales during the second half of 2020.

    Research and development expenses for the fourth quarter were $7.6 million versus $10.1 million for the comparable period in 2019 primarily driven by the reduction in force executed in the fourth quarter of 2019 and reduced clinical trial costs associated with the completion of the Phase 3 DEXTENZA allergic conjunctivitis trial and the Phase 3 OTX-TP trial, offset by increases in the costs associated with the Phase 1 clinical trials of OTX-TKI, OTX-TIC and OTX-CSI as well as the commencement of the Phase 2 clinical trial of OTX-CSI. Overall R&D expenses for the full year decreased $12.4 million to $28.7 million from $41.1 million in 2019, reflecting the trends identified above.

    Selling and marketing expenses for the fourth quarter were $6.8 million as compared to $7.1 million for the same quarter in 2019. The modest decrease relates to reduced consulting fees and travel-related costs offset by increased personnel costs. Overall, selling and marketing expenses for the full year increased to $26.6 million from $24.5 million in 2019, driven primarily by increased personnel costs offset by reduced spending on consulting, conferences and related costs.

    Finally, general and administrative expenses were $6.6 million for the fourth quarter versus $5.6 million in the comparable quarter of 2019. The increase in expenses stemmed primarily from increased personnel expenses and consulting fees. Overall, G&A expenses for the full year increased $0.8 million to $22.9 million from $22.1 million in 2019, again reflecting primarily increased personnel and consulting fees.

    With respect to financial results for the fourth quarter, the Company reported a net loss of $(85.6) million, or a loss of $(1.21) per share on a basic and diluted basis. This compares to a net loss of $(26.0) million, or a loss of $(0.54) per share on a basic and diluted basis for the same period in 2019. As operating expenses were modestly down quarter over quarter, the significant increase in loss was driven almost exclusively by a non-cash charge of $69.5 million related to the change in the fair value of the derivative liability associated with the Company's convertible notes. This change in fair value was due primarily to a 172% increase in the Company's common stock price during the fourth quarter of 2020 as compared to the third quarter of 2020. We expect the change in fair value of the derivative liability to continue to fluctuate until it is settled based on the extent changes occur in the underlying assumptions in calculating fair value including the price of the Company's common stock. The net loss for the fourth quarter also included $2.8 million in non-cash charges for stock-based compensation and depreciation compared to $2.6 million for the same quarter in 2019. Overall, the Company reported a net loss of $(155.6) million or a loss of $(2.56) per share on a basic and diluted basis for the full year ended December 31, 2020 versus a net loss of $(86.4) million or a loss of $(1.91) per share on a basic and diluted basis in 2019.

    As of March 2, 2021, the Company had 76.1 million shares outstanding.

    As of the full year ended December 31, 2020, the Company had $228.1 million in cash and cash equivalents versus $54.4 million at December 31, 2019. These cash amounts exclude restricted cash of $1.8 million. The cash balance benefited during the fourth quarter from $161.7 million in net proceeds from two follow-on equity offerings, one in October 2020 for $75.4 million in net proceeds and one in December 2020 for $86.3 million in net proceeds. Fourth quarter cash also benefited from proceeds of $12.0 million in upfront payments from the recently announced licensing agreement with AffaMed. For the full year ended December 31, 2020, cash and cash equivalents benefited from total net proceeds from financing activities of $228.0 million, including $48.3 million in net proceeds from a follow-on equity offering in May 2020 and $14.4 million in net proceeds from the sales of common stock under the Company's 2019 Sales Agreement earlier in the year. The May, October and December equity offerings were executed at public offering prices per share of $5.50, $9.75 and $21.50, respectively.

    Based on our 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, 2020, will enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements through 2023. This cash guidance is subject to a number of assumptions including those related to the severity and duration of the COVID-19 pandemic, the revenues and expenses associated with the commercialization of DEXTENZA, and the pace of research and clinical development programs, and other aspects of the 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 7189257. An archive of the webcast will be available until May 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 received a PDUFA target action date of October 18, 2021, for an sNDA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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 two 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 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 under transitional pass-through and to maintain the effectiveness of established reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes 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 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.

    Ocular Therapeutix, Inc.

      

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

    Year Ended

     

     

    December 31,

     

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    7,349

     

     

    $

    2,256

     

     

    $

    17,403

     

     

    $

    4,227

     

    Total revenue, net

     

     

    7,349

     

     

     

    2,256

     

     

     

    17,403

     

     

     

    4,227

     

    Costs and operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product revenue

     

     

    680

     

     

     

    839

     

     

     

    2,083

     

     

     

    2,325

     

    Research and development

     

     

    7,624

     

     

     

    10,125

     

     

     

    28,694

     

     

     

    41,091

     

    Selling and marketing

     

     

    6,811

     

     

     

    7,143

     

     

     

    26,614

     

     

     

    24,491

     

    General and administrative

     

     

    6,578

     

     

     

    5,551

     

     

     

    22,859

     

     

     

    22,122

     

    Total costs and operating expenses

     

     

    21,693

     

     

     

    23,657

     

     

     

    80,250

     

     

     

    90,029

     

    Loss from operations

     

     

    (14,344

    )

     

     

    (21,401

    )

     

     

    (62,847

    )

     

     

    (85,802

    )

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    6

     

     

     

    213

     

     

     

    168

     

     

     

    1,229

     

    Interest expense

     

     

    (1,725

    )

     

     

    (1,805

    )

     

     

    (6,768

    )

     

     

    (6,101

    )

    Change in fair value of derivative liability

     

     

    (69,549

    )

     

     

    (3,024

    )

     

     

    (86,189

    )

     

     

    4,310

     

    Other income (expense), net

     

     

     

     

     

     

     

     

     

     

     

    (8

    )

    Total other income (expense), net

     

     

    (71,268

    )

     

     

    (4,616

    )

     

     

    (92,789

    )

     

     

    (570

    )

    Net loss and comprehensive loss

     

    $

    (85,612

    )

     

    $

    (26,017

    )

     

    $

    (155,636

    )

     

    $

    (86,372

    )

    Net loss per share, basic

     

    $

    (1.21

    )

     

    $

    (0.54

    )

     

    $

    (2.56

    )

     

    $

    (1.91

    )

    Weighted average common shares outstanding, basic

     

     

    70,614,333

     

     

     

    48,489,846

     

     

     

    60,752,225

     

     

     

    45,273,231

     

    OCULAR THERAPEUTIX, INC.

      

    Consolidated Balance Sheets

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

    December 31,

     

    December 31,

     

     

    2020

     

    2019

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    228,057

     

     

    $

    54,437

     

    Accounts receivable, net

     

     

    12,252

     

     

     

    2,548

     

    Inventory

     

     

    1,201

     

     

     

    954

     

    Prepaid expenses and other current assets

     

     

    4,650

     

     

     

    2,231

     

    Total current assets

     

     

    246,160

     

     

     

    60,170

     

    Property and equipment, net

     

     

    8,095

     

     

     

    10,151

     

    Restricted cash

     

     

    1,764

     

     

     

    1,764

     

    Operating lease assets

     

     

    5,844

     

     

     

    6,655

     

    Total assets

     

    $

    261,863

     

     

    $

    78,740

     

    Liabilities and Stockholders' Equity (Deficit)

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    2,709

     

     

    $

    3,268

     

    Accrued expenses and other current liabilities

     

     

    14,307

     

     

     

    7,635

     

    Operating lease liabilities

     

     

    1,358

     

     

     

    1,126

     

    Notes payable, net of discount, current

     

     

    8,290

     

     

     

     

    Total current liabilities

     

     

    26,664

     

     

     

    12,029

     

    Other liabilities:

     

     

     

     

     

     

    Operating lease liabilities, net of current portion

     

     

    7,548

     

     

     

    8,905

     

    Derivative liability

     

     

    98,313

     

     

     

    12,124

     

    Deferred revenue

     

     

    12,000

     

     

     

     

    Notes payable, net of discount

     

     

    16,936

     

     

     

    25,007

     

    2026 convertible notes, net

     

     

    24,307

     

     

     

    24,305

     

    Total liabilities

     

     

    185,768

     

     

     

    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 December 31, 2020 and December 31, 2019, respectively

     

     

     

     

     

     

    Common stock, $0.0001 par value; 100,000,000 shares authorized and 75,996,732 and 50,333,559 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively

     

     

    8

     

     

     

    5

     

    Additional paid-in capital

     

     

    615,338

     

     

     

    379,980

     

    Accumulated deficit

     

     

    (539,251

    )

     

     

    (383,615

    )

    Total stockholders' equity (deficit)

     

     

    76,095

     

     

     

    (3,630

    )

    Total liabilities and stockholders' equity (deficit)

     

    $

    261,863

     

     

    $

    78,740

     

     

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  18. PDUFA Action Date Set 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 supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021. 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 have received…

    PDUFA Action Date Set 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 supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021. 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 have received a PDUFA date from the FDA for our sNDA seeking to potentially broaden the label of DEXTENZA," said Patricia Kitchen, Chief Operating Officer of Ocular Therapeutix. "An estimated 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 market for DEXTENZA beyond its current use in the surgical setting. The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis and if approved for this new proposed use, DEXTENZA could provide an office-based, physician administered, preservative-free method of steroid delivery that benefit patients with ocular itching associated with allergic conjunctivitis."

    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 (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.

    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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  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 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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  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 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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  21. 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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  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, 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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  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 (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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  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 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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  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 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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  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, 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: Prospectus_Department@Jefferies.com or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: prospectus@psc.com.

    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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  27. 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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  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 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: Prospectus_Department@Jefferies.com or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: prospectus@psc.com.

    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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  29. 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: Prospectus_Department@Jefferies.com or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: prospectus@psc.com.

    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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  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 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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  31. 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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  32. 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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  33. 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