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ENV515 from Envisia meets primary efficacy endpoint in phase 2a glaucoma trial

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ENV515 achieved its primary efficacy endpoint in reducing IOP in a phase 2a glaucoma clinical trial, according to an Envisia Therapeutics press release.

The proprietary, fully biodegradable PRINT travoprost formulation is designed to sustain IOP reductions for more than 6 months after a single dose without the need for additional eye drops.

A single-dose of ENV515 (travoprost XR) was administered in 10 eyes, and once-daily Travatan Z (travoprost ophthalmic solution 0.004%, Alcon) was administered in 21 eyes. Eyes that received ENV515 experienced a 6.7 mm Hg decrease (28%) in diurnal IOP at day 25 from baseline (P < .001). The result was comparable to the result with Travatan Z (6.6 mg Hg decrease, 28%), the release said.

“This phase 2a study outcome is a promising start in the clinical development of ENV515 and the goal of an extended-release therapy that has the potential to provide sustained IOP control for the vast majority of glaucoma patients for multiple months after a single dose,” lead investigator Steven L. Mansberger, MD, MPH, said in the release. “Poor patient compliance, which cannot be adequately addressed by topical therapies, has long been a significant challenge in the treatment of glaucoma, making it a leading cause of preventable blindness in the U.S. today.”

Envisia will advance ENV515 into a 12-month study to evaluate its long-term IOP-lowering effects, which have already been demonstrated up to 8 months after a single dose in preclinical trials, the release said.