Biopharmaceutical company Ocular Therapeutix, Inc. recently announced it had completed its End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.
Based on the review, Ocular Therapeutix plans to initiate the first of two Phase 3 clinical trials during the third quarter of 2016. The overall Phase 3 clinical trial will reportedly include an OTX-TP treatment arm and placebo-controlled arm that would use a non-drug eluting hydrogel-based intracanalicular depot, a Phase 3 study design will not include a timolol comparator or validation arm, and a primary efficacy endpoint of statistically superior and clinically meaningful reduction of intraocular pressure (IOP) from baseline with OTX-TP compared to placebo at 60 and 90 days.
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Source: Ocular Therapeutix, Inc.