Ocular Therapeutix Doses First Patient in Phase 3 Clinical Trial

Ocular Therapeutix (NASDAQ:OCUL) has announced it has dosed the first patients in its Phase 3 clinical trial of DEXTENZA to treat allergic conjunctivitis (AC).

As quoted in the press release:

 AC refers to inflammation of the conjunctiva of the eye caused by an allergic reaction – generally from airborne allergens – that affects approximately 70 million people in the United States and results in itching and burning of the eyes.

“We are pleased to be advancing DEXTENZA for allergic conjunctivitis,” said Antony Mattessich, President and Chief Executive Officer. “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. With the start of this Phase 3 trial, following the recent approval of DEXTENZA in the U.S. by the Food and Drug Administration (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.”

The Phase 3 clinical trial is a U.S.-based, multi-center, 1:1 randomized, double-masked, placebo-controlled trial that intends to enroll approximately 80 subjects. The study’s primary objective is to evaluate the safety and efficacy of DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg versus a placebo vehicle punctum plug using the Ophthalmic Research Associates’ modified Conjunctival Allergen Challenge (Ora-Cac^®) Model for the treatment of ocular itching associated with AC. The trial is designed to assess the effect of DEXTENZA compared with a placebo on allergic reactions using a series of successive allergen challenges over a 30-day period. The primary efficacy endpoint being evaluated in the study is ocular itching following insertion of DEXTENZA at multiple time points during the 30 day period. DEXTENZA is administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.

Click here to read the full press release.