Ocular Therapeutix (NASDAQ:OCUL) has dosed the first patients in its Phase 3 efficacy trial of DEXTENZA for the treatment of symptoms of allergic conjunctivitis (AC).
DEXTENZA is a corticosteroid that is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Administered by a physician, the bioresorbable intracanalicular insert is designed to deliver the drug to the ocular surface for up to 30 days.
The trial will enroll some 80 subjects to evaluate the safety and efficacy of DEXTENZA for the treatment of AC-related ocular itching, compared to placebo. The study’s primary efficacy endpoint is ocular itching following insertion of DEXTENZA at multiple time points during the 30-day period
“We believe DEXTENZA has the potential to replace the current standard of care eye drops with a one time, long-acting, seasonal therapy for the treatment of AC,” Antony Mattessich, Ocular Therapeutix’s president and CEO, said in a statement.
“With the start of this Phase 3 trial, following the recent approval of DEXTENZA in the U.S. by the FDA for the treatment of ocular inflammation and pain following ocular surgery, we are clearly focused on demonstrating DEXTENZA’s potential as a platform product for Ocular Therapeutix both in the surgical and outpatient settings,” he added.
Topline data from this trial are expected in the first half of 2020, and if positive, the company plans to submit a supplemental NDA to the FDA for ocular itching associated with AC.