Ocular Therapeutix announced positive topline data from the first of two Phase 3 clinical trials evaluating the safety and efficacy of OTX-DP (Sustained Release Dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery.
The Phase 3a and Phase 3b clinical trials were two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled clinical trials that were completed with a total of 487 patients (247 patients in Phase 3a and 240 in Phase 3b) undergoing unilateral clear corneal cataract surgery. Patients were randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. Both primary efficacy measures, differences in the proportion of patients in each treatment group with absence of cells in the anterior chamber of the study eye, at day 14 and absence of pain, at day eight were recorded at each study visit.
The Phase 3a study met both primary efficacy measures, achieving a statistically significant improvement in the reduction of inflammatory cells and pain. On day 14 following drug product insertion, 33.7% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye, compared to 14.6% of those receiving placebo vehicle control punctum plug (P=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day eight following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctum plug (P< 0.0001).
Ocular Therapeutix plans to submit a New Drug Application (NDA) to the FDA for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015 if both the Phase 3a and Phase 3b studies yield favorable results.
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