Ocular Therapeutix OTX-TP Intracanalicular Insert Fails to Meet Phase 3 Endpoint

Source: Ocular Therapeutix

Ocular Therapeutix’s intracanalicular insert failed to meet its primary endpoint of statistically significant superiority in mean reduction of IOP compared with placebo at all nine time points, according to a company news release.

OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of the drug travoprost for the reduction IOP in patients with primary open-angle glaucoma or ocular hypertension. OTX-TP is designed to lower IOP for up to 90 days and to address the poor adherence associated with chronic, daily eye drop regimens, the current standard of care.

The phase 3 randomized, double blind, placebo-controlled clinical trial was conducted across more than 50 sites and enrolled 554 subjects with open-angle glaucoma or ocular hypertension in the full analysis set (FAS) population. 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 nine different time points, three diurnal time points (8 AM, 10 AM, and 4 PM) at each of 2, 6, and 12 weeks following insertion.

Topline results show that the trial did not achieve its primary endpoint of statistically significant superiority in mean reduction of IOP compared with placebo at all nine time points. OTX-TP treated subjects did have a greater reduction in IOP from baseline relative to placebo insert at all nine time points, and these differences were statistically significant (P < 0.05) for eight of the nine time points (Table 1). The reductions from baseline for OTX-TP treated subjects in this trial ranged from 3.27-5.72 millimeters of mercury (mm Hg) across the nine time points with higher levels of intraocular pressure reduction seen at the earlier time points in this trial.

Table 1: Reduction in Intraocular Pressure (Change from Baseline)        
Diurnal Time points 2 Week 6 Week 12 Week
mm Hg p-value mm Hg p-value mm Hg p-value
OTX-TP Vehicle OTX-TP Vehicle OTX-TP Vehicle
8:00 AM -5.72 -3.88 <.0001 -4.81 -4.01 0.0181 -3.91 -3.52 0.2521
10:00 AM -4.92 -3.16 <.0001 -4.03 -3.23 0.0077 -3.34 -2.63 0.0234
4:00 PM -5.22 -3.18 <.0001 -4.16 -3.14 0.0004 -3.27 -2.60 0.0310
FAS Population (OTX-TP=343 subjects, Vehicle=211 subjects)     Least Squares (LS) Means

OTX-TP was generally well tolerated and no ocular serious adverse events were observed. The most common ocular adverse events seen in the study eye were dacryocanaliculitis (approximately 7% in OTX-TP vs. 3% in placebo) and lacrimal structure disorder (approximately 6% in OTX-TP vs. 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,” Michael Goldstein, MD, Chief Medical Officer, said in a company news 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.”

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