Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has enrolled its first patients in a phase III clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone, 0.4mg) for the treatment of allergic conjunctivitis. Dextenza is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.
This prospective, U.S.-based, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study is enrolling subjects who exhibit chronic signs and symptoms of allergic conjunctivitis. This is the first of two phase III studies and will evaluate Dextenza versus a placebo vehicle punctum plug using Ora’s modified Conjunctival Allergen Challenge (Ora-CAC) Model (Ora, Andover, Mass.), which accommodates for the longer therapeutic effect of a one-time administered sustained release drug product.
The study is designed to assess the effect of Dextenza compared with placebo on allergic reactions using three series of successive allergen challenges over a 30-day period. Dextenza or placebo will be administered 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 secondary efficacy measures for both itching and redness are measured at day 14 following insertion and on days 27-30 post-insertion.
Allergic conjunctivitis is an inflammatory disease of the conjunctiva resulting primarily from a reaction to allergy-causing substances such as pollen or pet dander. The primary sign of this inflammation is conjunctival redness and the primary symptom is acute ocular itching. Allergic conjunctivitis ranges in clinical severity from relatively mild, common forms to more severe forms that can cause impaired vision.