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Ocular's Glaucoma Drug Study Fails to Meet Primary Endpoint

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Ocular Therapeutix, Inc. (OCUL - Free Report) announced top-line results from the first pivotal phase III study on OTX-TP (sustained release travoprost)for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The study did not meet the primary endpoint and shares of the company fell 2.6% following the news. In fact, shares of Ocular have declined 15.3% year to date against the industry’s growth of 4.7%.


The study enrolled 554 subjects with open-angle glaucoma or ocular hypertension in the full analysis set (FAS) population. The primary endpoint of the study was reduction of intraocular pressure (IOP) from baseline on treatment with OTX-TP 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. 

Top-line results showed that the study did not achieve its primary endpoint of statistically significant superiority in mean reduction of IOP compared with placebo at all nine time points. However, OTX-TP treated subjects did have a statistically significant reduction in IOP from baseline relative to placebo insert at eight of the nine pre-specified time points.

OTX-TP was generally well tolerated and no ocular serious adverse events were observed.

Ocular will continue to review the data from the study and will meet the FDA for a discussion before determining the next steps in its clinical development plans.

We remind investors that in March 2019, Aerie Pharmaceuticals, Inc. (AERI - Free Report) received FDA approval for Rocklatan 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Rocklatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa (netarsudil) and Pfizer’s (PFE - Free Report) Xalatan (latanoprost).

Zacks Rank & Stock to Consider

Ocular currently has a Zacks Rank #3 (Hold).

A better-ranked stock in the same space is Eisai Co. (ESALY - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eisai’s earnings per share estimates have moved up from $1.86 to $1.95 for 2019 and from $1.89 to $2.02 for 2020 in the past 90 days.

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