Data from Phase 3 clinical trial demonstrate statistically significant effect achieved at all pre-specified primary endpoints
The Company intends to submit an sNDA to expand DEXTENZA’s label to include the treatment of ocular itching associated with allergic conjunctivitis in 2020
Conference call and webcast to take place today at 8:30 a.m. ET
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, 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.
“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.”
"Approximately 10-15 % of my allergic conjunctivitis patients are not adequately controlled with current therapy and thus require use of topical steroids. This patient group comprises commonplace seasonal and perennial allergic conjunctivitis as well as more severe atopic and vernal keratoconjunctivitis," stated Ken Kenyon, MD, an investigator in the DEXTENZA trial and Clinical Professor of Ophthalmology at Tufts / New England Eye Center. "Having a potent and effective anti-inflammatory medication to personally administer in the office setting without concern for patient compliance or potential misuse would be a great addition to my therapeutic toolbox."
The Phase 3 randomized, double-masked, parallel-arm, placebo-controlled clinical trial enrolled 96 subjects and was conducted across 6 sites in the U.S. using Ora, Inc.’s modified Conjunctival Allergen Challenge (Ora-CAC®) Model. The primary efficacy measure for this trial was ocular itching on Day 8 at 3 minutes, 5 minutes and 7 minutes post-challenge and included subjects with seasonal and perennial allergens. The trial’s primary endpoint was ocular itching measured on a 5-point scale (0 to 4) at three pre-specified time points on Day 8 (PM), 1 week after insertion of DEXTENZA. DEXTENZA-treated subjects demonstrated a statistically significant (p