US-based clinical-stage biotechnology firm Envisia Therapeutics has reported positive interim results from the second cohort of the ENV515 (travoprost XR) Phase II trial to treat patients with glaucoma.
ENV515 is a new, extended-release formulation of the prostaglandin analogue travoprost designed to decrease intraocular pressure (IOP) for more than six months from a single dose.
It is expected that the drug will inhibit disease progression and vision loss by increasing product performance and patient compliance.
The ongoing 12 month second cohort of the Phase II trial will evaluate the safety and efficacy of the candidate in five glaucoma patients enrolled at the US sites.
Envisia president Benjamin Yerxa said: "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.
"We continue to enrol 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."
Study results showed a decrease in intraocular pressure for the complete evaluation period (11 months) after a single administration.
The reduction in the IOP was found to be significant when compared to the prestudy topical prostaglandin analogs XALATAN and LUMIGAN, as well as in-study topical timolol maleate 0.5% ophthalmic solution.
Envisia Therapeutics leverages its PRINT technology to develop products to treat ocular disorders such as age-related macular degeneration (AMD), diabetic macular edema (DME) and ocular inflammation.
Image: Photograph showing an eye with glaucoma. Photo: courtesy of Jonathan Trobe / Wikipedia.