Envisia therapeutics releases interim Env515 phase 2 data results 

Clinical Trials

Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology released an interim analysis of the second cohort of its ENV515 (travoprost XR) phase 2 trial in patients with glaucoma.

It showing a clinically meaningful reduction in intraocular pressure (IOP) for the entire 11-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.

“A clinically meaningful reduction in IOP over the initial 11 months indicates that ENV515 has the potential to become a once a year therapy for glaucoma patients,” said Benjamin Yerxa, President of Envisia. “We continue to enroll patients into the next cohort of the study where we are studying ENV515 dose levels that have the potential to demonstrate a duration-of-action longer than the current 11 months.” 

Benjamin Yerxa will present the 11-month clinical data for Envisia’s ENV515 (travoprost XR) glaucoma program at the Glaucoma 360, New Horizon’s Forum today in San Francisco, CA. Glaucoma 360 is an annual meeting organized by the Glaucoma Research Foundation. 

“These eleven-month results demonstrate that ENV515 could achieve once a year dosing frequency which would be a very meaningful improvement over currently available daily therapies,” said Dr. Thomas Walters, MD, the lead investigator for the ENV515 phase 2 trial.

The ongoing second cohort of the phase 2 trial is a 12-month safety and efficacy evaluation that enrolled five glaucoma patients at sites within the U.S. The pre-washout baseline for all patients in this cohort, treated with LUMIGAN or XALATAN prior to enrollment, was 19.7 mmHg, with a post-washout baseline of 26.1 mmHg for 8 AM IOP. A single low dose of ENV515 decreased the mean + SD 8 AM IOP by 6.7 ± 3.7 mmHg or 25 percent over 11 months (mean of all 8 AM IOPs over eleven months). The mean 8 AM IOP after a single low dose of ENV515 was 19.5 mmHg over the 11-month period. There were no serious adverse events and the most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.

Envisia Therapeutics is a privately held biotechnology company focused on the development of novel ocular therapies. Envisia is leveraging the unique and powerful properties of the PRINT® technology to develop therapies for a variety of ocular conditions, beginning with ENV515 for glaucoma. ENV515 is a novel, extended-release formulation of a marketed prostaglandin analogue with the potential to significantly limit disease progression and vision loss through improved product performance and patient compliance. 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. Envisia is located in Research Triangle Park, North Carolina. For more information, please go to www.envisiatherapeutics.com

Envisia Therapeutics Media Contact: 
Michael Parks 484.356.7105 
This email address is being protected from spambots. You need JavaScript enabled to view it.