Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported positive results from an interim three-month analysis of an ongoing 12-month safety and efficacy evaluation of the low dosage form of ENV515 XR (travoprost). ENV515, the Company’s lead product candidate, 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 excited to report positive results for the low dosage form of ENV515, which demonstrated a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the entire three months,” said Benjamin Yerxa, President of Envisia. “These results enable us to move forward with the dose escalation study later this year, evaluating the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z with a duration greater than six months.”
Previously, a 28-day evaluation of the low dosage form of ENV515 demonstrated a reduction in IOP comparable to topical timolol, while the high dosage form of ENV515 demonstrated results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution). This second cohort of the ongoing phase 2 trial was a 12-month safety and efficacy evaluation of the low dosage form of ENV515 that was designed as an open-label trial that enrolled five glaucoma patients at sites within the U.S. The low dosage form of ENV515, administered once on Day 1, achieved the interim efficacy endpoint in this 3-month analysis, time-matched 8 AM IOP over the three-month post-dose period, with -7.1 mmHg or -27% change from IOP baseline that was comparable to topical timolol 0.5% twice daily with -7.4 mmHg or -28% change from IOP baseline, administered to the non-study eye. ENV515 was well tolerated and there were no serious adverse events, no changes in corneal endothelial cell counts evaluated by an independent reading center, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.
“Envisia’s extended delivery approach, leading to sustained IOP control without any loss of efficacy over time, may dramatically change the way we treat glaucoma in the majority of our patients,” said Dr. Thomas Walters, MD, the lead investigator for cohort 2 of the ENV515 phase 2 trial. “The current results position Envisia as one of the leaders in the field of ophthalmology.”
ENV515 is a fully biodegradable proprietary PRINT® nanoparticle formulation of a marketed prostaglandin analog that has the potential to lower IOP for more than six 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.