Envisia Therapeutics Announces First Patient Dosed in Second Cohort of Novel Phase 2 Program Evaluating ENV515 in Patients with Glaucoma

Positive Results from First Phase 2 Cohort Drives Expanded Patient Testing with Extended-Release Travoprost Formulation

Jan 12, 2016, 08:15 ET from Envisia Therapeutics

RESEARCH TRIANGLE PARK, N.C., Jan. 12, 2016 /PRNewswire/ -- Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced it has dosed its first patient in the second cohort of the phase 2 clinical program evaluating the Company's lead product candidate, ENV515. ENV515 is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose.

"We are encouraged by our initial clinical experience with ENV515 in glaucoma patients and have rapidly moved into the second cohort of our phase 2 program for advanced testing, which will provide more data in early 2016 to guide next steps for a larger, multi-center, masked trial," said Benjamin Yerxa, President of Envisia. "The progress of the ENV515 program further supports the potential of the proprietary PRINT® technology platform to accelerate drug development for front and back of the eye diseases."

"Envisia's novel approach may dramatically change the way we treat glaucoma, especially since poor patient adherence with eye drops is associated with blindness and visual impairment from glaucoma," 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. "This study may provide evidence that one-to-two injections per year of ENV515 in the doctor's office could control the IOP in most glaucoma patients without the need for them to apply daily eye drops."

ENV515 is a fully biodegradable proprietary PRINT® nanoparticle formulation of a marketed prostaglandin analog that has the potential to lower IOP for more than 6 months from a single dose.  ENV515 has the potential to address the issue of poor patient compliance that exists today with daily eye drops and limit the progression of glaucoma that sometimes leads to vision loss. Envisia is also leveraging the Company's unique platform technology to develop products for other leading ocular diseases including age-related macular degeneration (AMD), diabetic macular edema (DME), and ocular inflammation.

Initial clinical data from the first cohort were presented during the 2015 American Academy of Ophthalmology (AAO) Annual Meeting in Las Vegas, Nevada, November 13-17, 2015.  At that meeting, Dr. Mansberger presented data that showed ENV515, administered as a single dose, achieved its primary efficacy endpoint, a change from baseline in diurnal IOP at Day 25 (-6.7 mmHg or -28%, p<0.001, n=10), with comparable efficacy to once-daily TRAVATAN Z® (travoprost ophthalmic solution) (-6.6 mmHg or -28%, n=21).  ENV515 additionally demonstrated a strong safety profile and a sustained IOP-lowering effect over 25 days after a single dose.

ABOUT ENVISIA THERAPEUTICS™
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 platform 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.

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