Ocular enrolls first patient in Phase III trial of Dextenza to treat allergic conjunctivitis

Dextenza (sustained release dexamethasone, 0.4mg) is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.

People who exhibit chronic signs and symptoms of allergic conjunctivitis are being enrolled in this prospective, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled trial, which is the first of two Phase III trials.

The trial is designed to evaluate Dextenza versus a placebo vehicle punctum plug using Ora’s modified Conjunctival Allergen Challenge (Ora-CAC) Model which accommodates for the longer therapeutic effect of a one-time administered sustained release drug product.

During the trial, the effect of Dextenza will be evaluated compared with placebo on allergic reactions using three series of successive allergen challenges over a 30-day period.

Ocular Therapeutix president and CEO Amar Sawhney said: "This Phase III allergic conjunctivitis study marks our commitment to a clinical indication expansion strategy for Dextenza as we pursue both post-surgical pain and inflammation, and now allergic conjunctivitis.

"Severe allergy patients are often prescribed topical steroids for their condition, and we believe Dextenza may serve as an attractive alternative in treating allergic conjunctivitis due to its constant yet low-dose elution of therapy over an extended period."

Patients will be administered Dextenza or placebo for 48 to 72 hours after final confirmatory exposure to the allergen, and the primary endpoints to be evaluated are ocular itching and conjunctival redness at day seven following insertion.

The trial’s secondary efficacy measures for both itching and redness are measured at day 14 following insertion and on days 27-30 post-insertion.