Ocular Therapeutix: OTX-DP Phase 3a Trial Meets Primary Efficacy Measures

(RTTNews) - Ocular Therapeutix Inc. (OCUL) announced positive topline data from the first of two Phase 3 clinical trials evaluating the safety and efficacy of its product candidate, OTX-DP (Sustained Release Dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery. The company reported that its Phase 3a study met both primary efficacy measures, achieving a statistically significant improvement in the reduction of inflammatory cells and pain. Ocular said the company is continuing to analyze the safety findings from the clinical trial.

Ocular inflammation and pain are common side effects following ophthalmic surgery. Two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 clinical trials, referred to as the Phase 3a and Phase 3b clinical trials, were completed by the company with a total of 487 patients (247 patients in Phase 3a and 240 in Phase 3b) undergoing unilateral clear corneal cataract surgery. Topline data from the Phase 3b clinical trial are expected to be announced by the end of March.

Ocular Therapeutix said if the company obtains favorable aggregate results for both the Phase 3a and Phase 3b clinical trials, it expects to submit a New Drug Application (NDA) for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015.