OCT 08, 2015
Comprehensive Ophthalmology, Glaucoma
The first clinical trial of an extended-release formulation of travoprost shows it’s comparable to topical once-daily travoprost in patients with glaucoma.
Envisia Therapeutics developed PRINT (Particle Replication In Non-Wetting Templates) technology to design particles for extended-release formulations. The travoprost formulation, ENV515, is its first product candidate. If successful, Envisia says a single dose could offer sustained IOP reduction, without additional eye drops, for more than 6 months.
The phase 2a trial for ENV515 was designed as an open-label, 28-day dose-ranging study that enrolled 21 glaucoma patients in the United States to assess the initial efficacy and tolerability of ENV515.
ENV515, administered as a single dose, achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in IOP with results comparable to topical once-daily travoprost. At day 25, patients showed a reduction from baseline in diurnal IOP of 6.7 mmHg or 28%. The most common adverse event was transient hyperemia.
“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,” said Steven L. Mansberger, MD, MPH, Vice-Chair, Director of Glaucoma Services at Devers Eye Institute and lead investigator for the ENV515 phase 2a trial. “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 US today.”