Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company's lead product candidate, ENV515 (travoprost XR). In this phase 2a trial, ENV515 achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in intraocular pressure (IOP) with results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution). ENV515 is engineered as a proprietary, fully biodegradable PRINT® (Particle Replication In Non-Wetting Templates) travoprost formulation that could offer sustained reduction in IOP for more than six months after a single dose. Glaucoma is the leading cause of preventable blindness globally, which progresses in many cases due to a lack of patient compliance with currently available eye drops that must be administered daily. If successful, one-to-two injections of ENV515 a year in the doctor's office could satisfactorily control the IOP in most patients without the need for additional eye drops.
"We are excited to report positive results for ENV515 less than a year after initiating our first clinical study and we would like to thank the study investigators and their patients for helping us achieve this goal," said Benjamin Yerxa, President of Envisia. "The progress made with ENV515 underscores the power and flexibility of the PRINT platform to rapidly develop and advance promising small molecules and biologics for front and back of the eye diseases."
The ENV515 phase 2a clinical trial was designed as an open-label, 28-day dose-ranging study that enrolled 21 glaucoma patients at sites within the US to assess the initial efficacy and tolerability of ENV515. ENV515, administered as a single dose, achieved its primary efficacy endpoint, change from baseline in diurnal IOP at Day 25, by identifying a dose group (-6.7 mmHg or -28%, p<0.001, n=10) that is comparable to once-daily TRAVATAN Z® (travoprost ophthalmic solution) (-6.6 mmHg or -28%, n=21), administered to the non-study eye. The most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.
With these results, Envisia has chosen to advance ENV515 into a 12-month study that is designed to evaluate the long-term IOP-lowering effect of ENV515, which in pre-clinical studies demonstrated up to eight months of IOP-lowering effect after a single dose.
"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, M.D., 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."
Envisia leverages the power of the proprietary PRINT engineering and manufacturing platform to create extended-release ocular therapies that can deliver both small and large molecules in multiple formats. Envisia is actively exploring the use of the company's unique technology to develop products for other important ocular diseases including age-related macular degeneration (AMD), diabetic macular edema (DME), and ocular inflammation.
SOURCE Envisia Therapeutics