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Ocular Begins Enrollment In Phase III Trial On Glaucoma Drug

Published 10/04/2016, 10:02 PM
Updated 07/09/2023, 06:31 AM

Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced the enrollment of the first patient in one of the two planned phase III clinical trials on its pipeline candidate, OTX-TP (sustained release travoprost), for the treatment of glaucoma and ocular hypertension.

The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled phase III study will evaluate OTX-TP, in comparison with placebo, with no timolol comparator or validation arm. It is expected to enroll 550 patients across 50 clinical sites.

The primary endpoint of the study is reduction of intraocular pressure (IOP) from baseline on treatment with OTX-TP, compared to placebo, at 2, 6 and 12 weeks following insertion.

We note that the sustained nature of OTX-TP renders it the potential to improve the side effect profile and provide a convenient way to manage disease inpatients, who are not compliant with their therapy within the first six months of treatment.

The company expects top-line results from the first phase III study in the first half of 2018 and plans to commence the second phase III study in the first half of 2017.

Per the company’s press release, around 2.7 million people are diagnosed with glaucoma in the U.S. every year. According to data given by IMS Health, 34 million prescriptions and sales of drugs administered by eye drops of over $2.7 billion were generated last year. Thus, glaucoma represents huge market opportunity for Ocular Therapeutix.

Zacks Rank & Other Key Picks

Ocular Therapeutix currently carries a Zacks Rank #2 (Buy). Some other favorably placed stocks in health care sector include Anika Therapeutics Inc. (NASDAQ:ANIK) , Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika Therapeutics has seen its earnings estimates for 2016 and 2017 rise 9.4% and 11.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, with an average beat of 42.19%. Its share price has jumped 25.6% year to date.

Ariad Pharmaceuticals witnessed an increase of 68% in its 2016 earnings estimates, while that for 2017 remained mostly unchanged during the last 60 days. The company has beaten earnings estimates twice in the last four quarters, bringing the average surprise to 153.4%. The company’s stock price has surged 116.9% year to date.

ANI Pharmaceuticals witnessed an increase of 9.5% and 4.7% in its earnings estimates for 2016 and 2017, respectively, over the last 60 days. It has beaten earnings estimates twice in the last four quarters, taking the average to 46.85%. The company’s stock price has rallied 50.6% year to date.

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ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

ARIAD PHARMA (ARIA): Free Stock Analysis Report

OCULAR THERAPTX (OCUL): Free Stock Analysis Report

ANI PHARMACEUT (ANIP): Free Stock Analysis Report

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