Ocular Therapeutix says late-stage study of intracanalicular insert OTX-TP for glaucoma misses main goal

Ocular Therapeutix announced that a Phase III study of OTX-TP, an intracanalicular insert designed to deliver the drug travoprost, in patients with open-angle glaucoma or ocular hypertension failed to meet its primary endpoint. Top-line results showed that OTX-TP did not demonstrate significant superiority in mean reduction of intraocular pressure (IOP) compared with placebo at all nine time points in the trial.

The study randomised 554 people with open-angle glaucoma or ocular hypertension to receive OTX-TP or a placebo insert. The trial's primary efficacy endpoint was to demonstrate a statistically superior mean reduction of IOP from baseline with OTX-TP compared with placebo at nine different time points, three diurnal time points and at each of two weeks, six weeks and 12 weeks following insertion.

Ocular Therapeutix noted that while OTX-TP treated participants did have a greater reduction in IOP from baseline versus placebo at all nine time points, these differences were statistically significant for only eight of the time points. The reductions from baseline for OTX-TP treated participants ranged from 3.27 mm Hg to 5.72 mm Hg across the nine time points with higher levels of IOP reduction seen at the earlier time points. The company indicated that OTX-TP was generally well tolerated with no reports of ocular serious adverse events. The most common ocular adverse events were dacryocanaliculitis, evident in around 7 percent of the OTX-TP group and 3 percent for placebo, and lacrimal structure disorder, seen in about 6 percent and 4 percent of people in the two groups, respectively. 

Chief medical officer Michael Goldstein remarked that "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." The company said it plans to continue to review the data and discuss the results with the FDA and determine next steps.

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