A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure.
OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure.
The randomized, double-blind, placebo-controlled clinical trial took place across more than 50 sites with 554 subjects who had open-angle glaucoma or ocular hypertension in the full analysis set population. The primary efficacy endpoint was a statistically superior mean reduction of IOP compared with a placebo insert at nine times and three diurnal time points at two, six and 12 weeks.
The trial did not achieve the primary endpoint of statistically significant superiority in the reduction of IOP compared with placebo at all nine point times. The differences were statistically significant for eight of the nine time points, according to the company. Reductions from baseline ranged from 3.27 to 5.72 mm of mercury across all nine time points with higher intraocular pressure reduction at earlier time points in the trial.
Ocular Therapeutix said that the OTX-TP was generally well tolerated with no serious adverse events reported. The most common adverse effect was dacryocanaliculitis (7% in OTX-TP and 3% in placebo) and lacrimal structure disorder (6% in OTX-TP and 4% in placebo).
“We are encouraged by the results of this trial which shows OTX-TP’s ability to lower IOP out to 12 weeks with a single insert using this novel dosage form,” Dr. Michael Goldstein, chief medical officer, said in a press release. “In our opinion, this product candidate represents a new opportunity for treating glaucoma patients that has the potential to address one of the biggest issues we deal with in clinical practice, the challenges patients have in taking eye drops. 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.”