Article

Ocular Therapeutix 90-Day Insert Barely Misses Endpoint

■ Ocular Therapeutix announced top-line results from the first pivotal, phase 3 clinical trial of OTX-TP, an intracanalicular insert that delivers a preservative-free formulation of travoprost for the reduction of IOP in patients with POAG or OHTN. The data were promising, the company said, but did not meet the primary endpoint of the study.

OTX-TP is designed to lower IOP for up to 90 days and to address the poor compliance associated with chronic, daily eye-drop regimens. The randomized, double-blind, placebo-controlled clinical trial was conducted across more than 50 sites and enrolled 554 subjects. The trial’s primary efficacy endpoint was to demonstrate a statistically superior mean reduction of IOP from baseline for OTX-TP-treated subjects compared with placebo insert-treated subjects at 3 diurnal time points each at 2, 6, and 12 weeks following insertion. Top-line results show that the trial did not achieve its primary endpoint of statistically significant superiority in mean reduction of IOP compared with placebo at any of the 9 time points.

OTX-TP-treated subjects did have a greater reduction in IOP from baseline relative to placebo insert at all 9 time points, and these differences were statistically significant for 8 of the 9 points. The reductions from baseline for OTX-TP-treated subjects in this trial ranged from 3.27 mmHg to 5.72 mmHg across the 9 time points, with higher levels of IOP reduction seen at the earlier time points. OTX-TP was generally well tolerated, and no ocular serious adverse events were observed.

“We will continue to review the data from the trial, and we look forward to meeting with the FDA to discuss these results before determining the next steps in our clinical development plans,” stated Michael Goldstein, MD, chief medical officer of Ocular Therapeutix.