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OCUL

Ocular Therapeutix

$3.35 /

-0.11 (-3.18%)

16:06
05/20/19
05/20
16:06
05/20/19
16:06

Ocular Therapeutix says OTX-TP failed to meet primary endpoint in Phase 3 trial

Ocular Therapeutix announced topline results from the first pivotal Phase 3 clinical trial of OTX-TP, an intracanalicular insert that delivers a preservative-free formulation of the drug travoprost for the reduction of intraocular pressure 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 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 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 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 across the nine time points with higher levels of intraocular pressure reduction seen at the earlier time points in this trial. 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 and lacrimal structure disorder. "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," stated Michael Goldstein, MD, Chief Medical Officer. "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."

  • 11

    Jun

  • 10

    Nov

OCUL Ocular Therapeutix
$3.35 /

-0.11 (-3.18%)

03/28/19 Piper Sandler
Ocular Therapeutix's Dextenza may provide substantial upside, says Piper Jaffray
03/08/19 Piper Sandler
Ocular undervalued ahead of glaucoma data, says Piper Jaffray
01/04/19 Piper Sandler
Piper sees 'significant share appreciation' potential for Ocular Therapeutix
12/04/18 H.C. Wainwright
Ocular Therapeutix price target raised to $12 from $10 at H.C. Wainwright

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