\nOcular 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.\n<\/p>\n
\n\u201cAt ASCRS, we will be presenting data on multiple programs we are advancing in the clinic as well as DEXTENZA\u00ae (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use which is commercially available to treat post-operative ocular inflammation and pain and ReSure\u00ae Sealant, an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery,\u201d commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. \u201cThe 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.\u201d\n<\/p>\n
Ocular Therapeutix Presentations at ASCRS:<\/b><\/p>\n
DEXTENZA\u00ae (Post-operative Ocular Inflammation and Pain):<\/span><\/b><\/p>\n \nSession Title: Medications (Preoperative, Postoperative, Intraoperative)\n<\/p>\n \nSession Date\/Times: Monday, July 26, 2021 at 10:45 AM-10:50 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: John D Stephens, MD\n<\/p>\n \nASCRS Paper ID: 76462\n<\/p>\n \nSession Title: Medications (Preoperative, Postoperative, Intraoperative)\n<\/p>\n \nSession Date\/Times: Monday, July 26, 2021 at 10:55 AM-11:00 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Cynthia Matossian, MD\n<\/p>\n \nASCRS Paper ID: 76483\n<\/p>\n OTX-DP (dexamethasone ophthalmic insert, 0.4 mg) (Allergic Conjunctivitis):<\/span><\/b><\/p>\n \nSession Title: Ocular Surface II\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 1:40 PM-1:45 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Lisa Nijm, JD, MD, ABO\n<\/p>\n \nASCRS Paper ID: 76511\n<\/p>\n \nSession Title: Ocular Surface II\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 1:45 PM-1:50 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Jay M Rubin, MD\n<\/p>\n \nASCRS Paper ID: 76531\n<\/p>\n Pipeline: <\/span><\/b><\/p>\n \nSession Title: Ocular Surface II\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 1:35 PM-1:40 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Lee Shettle, DO\n<\/p>\n \nASCRS Paper ID: 76276\n<\/p>\n \nSession Title: Glaucoma – Medications\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 2:30 PM-2:35 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Lagoon F\n<\/p>\n \nPresenter: Thomas Walters, MD\n<\/p>\n \nASCRS Paper ID: 76727\n<\/p>\n ReSure\u00ae Sealant:<\/span><\/b><\/p>\n \nSession Title: Surgical Comparisons\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 8:30 AM-8:35 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf CD\n<\/p>\n \nPresenter: Leon Herndon, MD\n<\/p>\n Other:<\/span><\/b><\/p>\n \nSession Title: Surgical Outcomes\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 8:32 AM-8:37 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf EF\n<\/p>\n \nPresenter: Michael H Goldstein, MD\n<\/p>\n \nASCRS Paper ID: 76786\n<\/p>\n Investigator-Initiated Trials Presented at ASCRS:<\/span><\/b><\/p>\n \nSession Title: Refractive Outcomes\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 8:15 AM-8:20 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Brian M Shafer, MD\n<\/p>\n \nSession Title: Crosslinking\/Corneal Infectious Diseases\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 1:30 PM-1:32 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf EF\n<\/p>\n \nPresenter: Eric D Rosenberg, DO, MSE\n<\/p>\n \nSession Title: Glaucoma- Medications\n<\/p>\n \nSession Date\/Times: Sunday, July 25, 2021 at 2:35 PM-2:40 PM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Lagoon F\n<\/p>\n \nPresenter: Inder P Singh, MD\n<\/p>\n \nSession Title: Medications (Preoperative, Postoperative, Intraoperative)\n<\/p>\n \nSession Date\/Times: Monday, July 26, 2021 at 10:10 AM-10:15 AM PT\n<\/p>\n \nLocation: MBCR \u2013 Level 2, Surf AB\n<\/p>\n \nPresenter: Brian B Foster, MD, ABO\n<\/p>\n \nCornea Posters available On-Demand\n<\/p>\n \nPresenter: Haroon Ilyas, MD\n<\/p>\n About Ocular Therapeutix, Inc. <\/b><\/p>\n \nOcular 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\u2019s first commercial drug product, DEXTENZA\u00ae, 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\u2019s 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\u00ae Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.\n<\/p>\n Forward Looking Statements<\/b><\/p>\n \nAny statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA\u00ae, ReSure\u00ae Sealant, or any of the Company\u2019s 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\u2019s product candidates, such as the Company\u2019s 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\u2019s extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company\u2019s 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\u2019s product candidates, if approved; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company\u2019s 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\u2019s 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\u2019s scientific approach and general development progress, the availability or commercial potential of the Company\u2019s product candidates, the Company\u2019s 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\u2019s existing indebtedness, the ability of the Company\u2019s 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\u2019s and relevant regulatory authorities\u2019 operations, any additional financing needs and other factors discussed in the \u201cRisk Factors\u201d section contained in the Company\u2019s 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\u2019s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company\u2019s 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\u2019s views as of any date subsequent to the date of this press release.\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210723005093\/en\/<\/a><\/span><\/p>\n Investors \nor\n<\/p>\n \nWestwicke, an ICR Company Media KEYWORDS:<\/b> United States North America Massachusetts<\/p>\n INDUSTRY KEYWORDS:<\/b> Research Surgery Clinical Trials Biotechnology Health Pharmaceutical Optical Other Science Science<\/p>\n\n
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<\/b>Ocular Therapeutix
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Donald Notman
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Chief Financial Officer
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dnotman@ocutx.com<\/a><\/p>\n
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Chris Brinzey, 339-970-2843
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Managing Director
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chris.brinzey@westwicke.com<\/a><\/p>\n
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<\/b>Ocular Therapeutix
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Scott Corning
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Senior Vice President, Commercial
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scorning@ocutx.com<\/a><\/p>\n
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