Ocular Therapeutix™ To Present Data at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting
“We are presenting two posters and a paper at this year’s
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
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
Senior Vice President, Commercial