DEC 16, 2015
Comprehensive Ophthalmology, Cornea/External Disease
Ocular Therapeutix announced promising topline results from a phase 2 exploratory clinical trial of sustained-released dexamethasone (Dextenza) for inflammatory dry eye disease.
Dextenza is a bioresorbable intracanalicular depot designed for extended drug release to the ocular surface for 30 days. The prospective, randomized, double-masked, placebo controlled study was designed to explore the safety and efficacy of Dextenza for patients exhibiting signs and symptoms of moderate to severe dry eye disease. Patients were initially administered a placebo vehicle depot for 45 days to establish a baseline and those who responded positively to the placebo were excluded from the treatment phase of the study. The 43 patients (86 eyes) who continued to exhibit signs and symptoms of dry eye were randomized to receive either Dextenza or a placebo vehicle.
Although this study was not powered for statistical significance, the Dextenza group showed significantly improved total corneal staining compared to the placebo group (P =0.018). The study group also showed favorable results for inferior staining, lissamine green staining as well as frequency and severity of dry eye symptoms. Dextenza was well tolerated and no IOP spikes were reported.
Dextenza is also in phase 3 trials for the treatment of allergic conjunctivitis and postoperative inflammation and pain.