Ocular Therapeutix starts enrollment in Phase 3 clinical trial with OTX-TP
Ocular Therapeutix announced the enrollment of the first patient in the first of two planned Phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension. OTX-TP is a preservative-free drug product candidate that resides within the canaliculus and is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days. The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled study is expected to enroll approximately 550 patients with open angle glaucoma or ocular hypertension at 50 clinical sites. Importantly, the Phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm. The comparator arm will utilize a non-drug eluting hydrogel-based intracanalicular insert. The primary efficacy endpoint will be statistically superior reduction of intraocular pressure from baseline with OTX-TP compared to placebo at 2, 6 and 12 weeks following insertion.