BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple presentations at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting, May 16-17, 2020.
"We are thrilled with the clinical benefits we have seen with DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery as well as the results from the recently disclosed Phase 3 clinical trial for ocular itching associated with allergic conjunctivitis,” commented Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. “The presentations at ASCRS highlight both the physician and patient experiences with DEXTENZA, as well as its clinical benefit in the operating room and potentially in the office setting. We are also excited about the acceptance of our late-breaking abstract and the ability to present Phase 3 data on DEXTENZA in allergic conjunctivitis. In addition, the data being presented in glaucoma continue to highlight the strength of our hydrogel platform that is used throughout our pipeline of product candidates being developed for both front- and back-of-the-eye diseases.”
Paper Presentations at ASCRS:
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Dropless Punctal Plug Dexamethasone, Intracameral Ketorolac and Moxifloxacin Compared to Conventional Topical Therapy in Cataract Surgery. Donnenfeld ED, Hovanesian JA, Hummel CD, Quintero JA
Saturday May 16, 2020; 9:05 AM – 9:10 AM
VM-1, Virtual Room 4
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Patient and Physician Preference for an Intracanalicular Dexamethasone Insert for Treating Inflammation and Pain Following Cataract Surgery. McCabe CM, Berdahl JP, Tyson S, Singh IP, Vantipalli S, Metzinger JL, Goldstein MH
Saturday, May 16, 2020; 9:10 AM – 9:15 AM
VM-1, Virtual Room 4
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Assessment of the Cumulative DEXTENZA Drug Effect Compared to Placebo in the Pooled Phase 3 Studies via Area Under the Curve (AUC) Analysis. Mah F, Feng MT, Raizman M, Silverstein B, Vantipalli S, Metzinger JL, Goldstein MH, Gibson AA
Saturday, May 16, 2020; 9:15 AM – 9:20 AM
VM-1, Virtual Room 4
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Resolution of Inflammation and Pain Following Cataract Surgery with an Intracanalicular Dexamethasone Insert. Khandelwal SS, Levenson JH, Gira JP, Vantipalli S, Metzinger JL, Goldstein MH
Saturday, May 16, 2020; 9:20 AM – 9:25 AM
VM-1, Virtual Room 4
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Vision Outcomes Following Cataract Surgery with an Intracanalicular Dexamethasone Insert for Treating Postoperative Inflammation and Pain. Silverstein SM, Hovanesian JA, Bafna S, Epitropoulos AT, Vantipalli S, Metzinger JL, Goldstein MH
Saturday, May 16, 2020; 9:59 AM – 10:04 AM
VM-1, Virtual Room 4
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Phase 3 Trial Evaluating an Intracanalicular Dexamethasone Insert (0.4 mg) for the Treatment of Patients with Allergic Conjunctivitis. Kenyon KR, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RR, Goldstein MH
Saturday, May 16, 2020; 10:16 AM – 10:21 AM
VM-1, Virtual Room 4
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Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma – Phase 1 Trial. Walters TR, Goldberg D, Bacharach J, Braun EM, Vantipalli S, Metzinger JL, Goldstein MH
Saturday, May 16, 2020; 3:25 PM – 3:30 PM
VM-1, Virtual Room 7
Abstracts and full session details can be found at www.ascrs.org.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis and intends to file an sNDA by the end of 2020. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company’s earlier stage development assets include OTX-CSI, an intracanalicular insert for the treatment of dry eye disease, OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure Sealant, or any of the Company’s product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the presentation of data on the Company’s products and product candidates at medical conferences; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any of the Company’s product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company’s ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, the need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.
