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Ocular Therapeutix™ Announces Topline Results of Phase 3 Clinical Trial of DEXTENZA® for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Data from Phase 3 clinical trial demonstrate statistically significant effect achieved at all pre-specified primary endpoints The Company intends to submit
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"\nData from Phase 3 clinical trial demonstrate statistically significant effect achieved at all pre-specified primary endpoints\n\n\nThe Company intends to submit an sNDA to expand DEXTENZA’s label to include the treatment of ocular itching associated with allergic conjunctivitis in 2020\n\n\nConference call and webcast to take place today at 8:30 a.m. ET\n\n BEDFORD, Mass.--(BUSINESS WIRE)--\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, today announced topline results from its Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA® for the treatment of ocular itching associated with allergic conjunctivitis (AC). We believe our product DEXTENZA for AC has potential as a hands-free therapy administered in the office setting as a bioresorbable, intracanalicular insert, designed to release the corticosteroid dexamethasone to the ocular surface for up to 30 days. In the Phase 3 trial, DEXTENZA met all pre-specified primary endpoints as demonstrated by a statistically significant mean change in ocular itching from baseline, on a subject-reported 5-point scale, at three time points on Day 8.\n\n\n“We are thrilled with the results from the Phase 3 clinical trial and believe the data highlights a compelling product profile that could potentially change the current standard of care with a one-time, long-acting, hands-free, therapy for the treatment of allergic conjunctivitis,” said Michael Goldstein, MD, Chief Medical Officer. “The allergic conjunctivitis market is currently dominated by topical antihistamine/mast cell stabilizers. There is a large unmet need for a potent, hands-free and preservative-free topical anti-inflammatory medication for those subjects who need more than what it is currently available to them. Even in normal times, the hassle of using topical eye-drops for patients and the worry of non-compliance for physicians are problematic. In the era of COVID-19, having a full course of steroid treatment in a single physician-administered insert that doesn’t require patients to touch their face multiple times per day is an even greater breakthrough.”\n\n\n\"Approximately 10-15 % of my allergic conjunctivitis patients are not adequately controlled with current ...