Envisia Therapeutics announced that it has dosed its first patient in the second cohort of the phase 2 clinical program evaluating the company’s lead product candidate, ENV515, according to a company news release. ENV515 is an extended-release formulation of travoprost that could offer sustained reduction in IOP for more than 6 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, multicenter, masked trial,” Benjamin Yerxa, president of Envisia, said in teh news release. “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,” Steven L. Mansberger, MD, MPH, Vice-Chair, Director of Glaucoma Services at Devers Eye Institute and lead investigator for the ENV515 phase 2a trial, said in the news release. “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, according to the news release.
Initial clinical data from the first cohort were presented during the 2015 American Academy of Ophthalmology (AAO) annual meeting in Las Vegas, 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.