About Us | ScientistOCUL Ocular Therapeutix Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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DEXTENZA
Allergic conjunctivitis
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PDUFA
PDUFA
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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OTX-CSI
Dry eye disease (DED)
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Phase 2
Phase 2
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OTX-DED
Dry eye disease
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
OTX-TKI
Wet Age-related Macular Degeneration (AMD)
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Phase 1
Phase 1
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Phase 1 initiation of dosing (U.S. trial) announced July 29, 2021.
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OTX-TIC
Glaucoma and ocular hypertension
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Phase 1
Phase 1
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Phase 1 data presented at ARVO May 2021. Phase 2 trial to commence 4Q 2021.
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DEXTENZA
Post-surgical ocular inflammation and pain - children
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Phase 3
Phase 3
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Phase 3 initiation of dosing announced September 10, 2020.
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OTX-TP
Glaucoma and ocular hypertension
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Phase 3
Phase 3
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Phase 3 data May 20, 2019 did not meet primary endpoint.
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DEXTENZA
Ocular inflammation and pain following cataract surgery
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Approved
Approved
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FDA approval announced December 3, 2018.
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DEXTENZA
Post-surgical ocular inflammation and pain
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Approved
Approved
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FDA Approval June 21, 2019.
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Latest News
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210729005328/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005215/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210723005093/en/
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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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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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