EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 PAVIA Trial of EYP-1901 for the Treatment of Non-Proliferative Diabetic Retinopathy
EyePoint Pharmaceuticals announced that the first patient has been dosed in the phase 2 PAVIA clinical trial of EYP-1901, a potential sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting non-proliferative diabetic retinopathy (NPDR).
“We are excited to announce the first patient dosing of the phase 2 PAVIA clinical trial of EYP-1901 for NPDR, a serious eye disorder affecting almost one-third of adults over the age of 40 with diabetes that can lead to severe vision loss if left uncontrolled,” Jay Duker, MD, Chief Operating Officer of EyePoint Pharmaceuticals, said in a company news release. “Despite the severe nature of this disease, the current standard-of-care is no treatment until a patient develops sight-threatening complications. There remains a lack of approved treatments for this serious eye disease, leaving a significant opportunity for a long-acting treatment option that maintains the patient’s existing vision proactively. Building on EYP-1901’s excellent safety and efficacy results from our phase 1 DAVIO trial in wet AMD, we believe that EYP-1901 has the potential to improve the current treatment paradigm as a sustained delivery maintenance treatment for NPDR and significantly improve the lives of patients living with this serious eye disorder.”
The 12-month, randomized, controlled phase 2 PAVIA clinical trial of EYP-1901 for NPDR is expected to enroll approximately 105 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) severity levels as of week 36 after the EYP-1901 injection. Secondary endpoints include vision-threatening complications, occurrence of DME and/or proliferative disease, retinal ischemia/nonperfusion and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05383209).
About EYP-1901
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO phase 1 clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to 6 and 12 months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned for diabetic macular edema in 2023. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.