Ocular Begins Enrollment In Phase III Trial On Glaucoma Drug
Zacks Investment Research | Oct 04, 2016 10:02PM ET
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.
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