Envisia Therapeutics released an interim analysis of the second cohort of its ENV515 (travoprost XR) phase 2 trial in patients with glaucoma showing a clinically meaningful reduction in 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), according to a company news release.
"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," Benjamin Yerxa, President of Envisia, said in the news release. "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. 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," Thomas Walters, MD, the lead investigator for the ENV515 phase 2 trial, said in the news release.
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 11 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.