Why Ocular Therapeutix Fell Short in Its Glaucoma Study

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Ocular Therapeutix Inc. (NASDAQ: OCUL) shares took a beating on Tuesday after the firm announced late-stage results for patients with primary open-angle glaucoma or ocular hypertension. These results come from the Phase 3 clinical trial of OTX-TP, which seeks to reduce the intraocular pressure in these patients.

Unfortunately, OTX-TP failed to meet primary endpoint but achieved statistically significant reduction of intraocular pressure (IOP) compared with placebo at eight of the nine pre-specified time points.

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.

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 for eight of the nine time points.

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.

Michael Goldstein, M.D., chief medical officer, commented:

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. 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.

Shares of Ocular Therapeutix were last seen down 26% at $2.50, in a 52-week range of $2.35 to $8.27. The consensus price target is $13.83.


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