Ocular Therapeutix (NASDAQ:OCUL) has completed an end-of-Phase 2 review with the FDA for its sustained release travoprost product candidate, OTX-TP, for the treatment of glaucoma and ocular hypertension and intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.
The FDA has stated that it agrees with the overall Phase 3 clinical development program proposed by Ocular in its briefing package submitted to the FDA.
A primary efficacy endpoint is statistically superior and clinically meaningful reduction of intraocular pressure (IOP) from baseline with OTX-TP, compared with placebo at 60 and 90 days.
The FDA has also indicated that it will take into consideration the risk-reward profile of OTX-TP relative to
currently available therapies in its evaluation of the Phase 3 results.
In a statement, Amar Sawhney, president, chairman and CEO, said OTX-TP has shown a clinically meaningful IOP-lowering effect in clinical trials to date, and may offer an important advancement in the treatment of glaucoma.
“We believe OTX-TP may be able to address the major issue of low patient compliance rates associated with currently approved topical therapies and their chronic, burdensome dosing schedules, while potentially improving the safety profile due to the absence of preservatives,” he added.