Ocular Therapeutix announced topline efficacy results from a Phase 3 clinical trial evaluating the safety and efficacy of Dextenza (sustained release dexamethasone) 0.4 mg, Intracanalicular Depot for the treatment of allergic conjunctivitis.
The Phase 3 study, a multicenter, randomized, parallel-arm, double-masked, vehicle-controlled trial in 73 patients, is the first of two planned Phase 3 studies evaluating Dextenza vs. a placebo drug delivery vehicle using the modified Ora-CAC (Conjunctival Allergen Challenge) model. The study was designed to assess the effect of Dextenza vs. placebo on allergic reactions using four series of successive allergen challenges over a 30-day period. The primary efficacy endpoints were differences in mean ocular itching scores and conjunctival redness between the treatment group and the placebo group 7 days after insertion of the drug product.
The primary endpoint for ocular itching was met, showing statistically significant difference (P<0.0001) in the mean ocular itching scores between the Dextenza treatment group and the placebo group at all three time points measured on Day 7 post drug insertion. Dextenza did not achieve the primary endpoint for conjunctival redness in this trial, however, this endpoint has not been required for approval but is typically included in Phase 3 trials for allergic conjunctivitis.
Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for extended drug release to the ocular surface for 30 days.
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