EyePoint Pharmaceuticals, Inc. announced it has completed enrollment in the phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential nine-month treatment for moderate to severe non-proliferative diabetic retinopathy (NPDR).
“We are delighted to report the completion of enrollment in the phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential nine-month treatment for NPDR,” said Nancy Lurker, CEO of EyePoint Pharmaceuticals. “We are particularly pleased to have enrolled 77 patients in this trial, exceeding the 60 patient target, and look forward to reporting topline data in the second quarter of 2024. We are excited about the potential of EYP-1901 in NPDR. Despite the risk for visual loss associated with this disease, over 90% of patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. This is due to the burdensome and frequent eye injections currently required with today’s approved therapies for this disease. As a result, we believe EYP-1901 may address the substantial therapeutic unmet need for a long-acting treatment.”
PAVIA is a 12-month, randomized, controlled phase 2 clinical trial of EYP-1901 in patients with moderate to severe NPDR. The trial enrolled 77 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg), or to the control group receiving a sham injection. EYP-1901 is delivered with a single intravitreal injection in the physician's office. The primary efficacy endpoint of the trial is improvement of at least two diabetic retinopathy severity scale (DRSS) levels as of week 36 after the EYP-1901 injection. Secondary endpoints include reduction in vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05383209).
“NPDR is a serious eye disorder affecting almost one-third of adults over the age of 40 with diabetes. It can lead to severe vision loss if left uncontrolled, however, the only approved treatments for this chronic disease are short-acting and require frequent office visits and intraocular injections. This leads to a passive treatment approach with no active drug therapy as the existing standard-of-care,” said Jay S. Duker, MD, President and COO of EyePoint Pharmaceuticals. “There was a high-level of enthusiasm from practitioners, caregivers, and patients during the enrollment of the PAVIA trial, and, speaking from my experience as a practicing retina specialist, I am incredibly excited about the potential of treating NPDR patients with EYP-1901 every 9-months or longer to actively safeguard patients’ vision between eye examinations. We thank the trial investigators, patients, and our internal team for completing trial enrollment swiftly and for their continued confidence in EYP-1901.”
About EYP-1901
EYP-1901 is being developed as an investigational sustained delivery treatment for retinal disease combining an erodible formulation of EyePoint's proprietary Durasert delivery technology (Durasert E with vorolanib, a tyrosine kinase inhibitor.
Positive safety and efficacy data from the Phase 1 DAVIO clinical trial of EYP-1901 in wet AMD showed a positive safety profile with stable visual acuity and OCT. Further, the data demonstrated an impressive treatment burden reduction of 75% at six months and 73% at the 12-month visit following a single dose of EYP-1901. Phase 2 trials are fully enrolled in wet AMD and non-proliferative diabetic retinopathy, and a diabetic macular edema trial is planned for initiation in Q1 2024. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.