Sustained release OTX-TP reduces IOP in phase 2b clinical trial

Ocular Therapeutix announced that sustained release OTX-TP achieved “clinically meaningful” reduction in IOP in its phase 2b study, according to a press release reporting topline results.

OTX-TP (sustained release travoprost) is intended for treatment of glaucoma and ocular hypertension.

The prospective, multicenter, double-masked, double dummy, parallel-arm active controlled study randomized 73 patients to receive either OTX-TP or timolol. Clinically meaningful IOP lowering of 4.5 mm Hg to 5.7 mm Hg was observed at 90 days in the OTX-TP arm. In the timolol arm in the presence of a placebo depot, IOP lowering was better than expected, suggesting that “performance may be improved by placebo plug,” the release said.

The 90-day safety and efficacy trial was not powered to compare IOP lowering between the two groups, according to the release, and no adverse events related to OTX-TP were seen.

“The effect on IOP lowering observed with OTX-TP was similar to what we observed in our phase 2a study and reached a clinically meaningful level. We also observed a significant improvement in retention of the depot over prior studies through day 75, achieving 88% retention in the combined arms in the study,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix said in the release.

The company plans to incorporate findings from the phase 2b trial into their program and advance a 75-day drug delivery product to phase 3 trial in the second half of 2016, Sawhney said in the release.