EyePoint Pharmaceuticals reports mixed results for DURAVYU in Phase 2 diabetic retinopathy trial

EyePoint Pharmaceuticals, Inc., committed to innovative therapeutics for serious retinal diseases, today disclosed the top-line results of the Phase 2 PAVIA clinical trial for DURAVYU (previously known as EYP-1901). This trial evaluated DURAVYU in patients with non-proliferative diabetic retinopathy (NPDR), revealing that while the treatment exhibits a biologic effect and a favorable safety profile, it did not meet the pre-specified primary efficacy endpoint. The company has announced plans to conduct a detailed analysis of the full 12-month data to determine the future direction of DURAVYU in NPDR treatment.

Detailed Outcomes and Future Directions

Dr. Jay Duker, CEO of EyePoint Pharmaceuticals, expressed a cautious optimism: “Although the trial did not meet the pre-specified primary endpoint, we are encouraged that DURAVYU continues to be well tolerated and appears to reduce rates of NPDR progression at nine months,” he said. The PAVIA trial’s preliminary findings at nine months indicate that 86% of patients in the 3mg dose arm and 80% in the 2mg dose arm experienced stable or improved disease states, compared to 70% in the control group.

The company eagerly anticipates the completion of the full twelve-month trial data, which will provide clearer insights into DURAVYU’s efficacy and inform the path forward for its development in treating NPDR.

EyePoint Pharmaceuticals shares interim Phase 2 PAVIA trial results for DURAVYU, revealing promising safety but missing primary endpoints in NPDR treatment.

Continued Focus on Upcoming Trials

EyePoint Pharmaceuticals is not slowing down its research efforts despite the mixed results. Dr. Duker highlighted the company’s commitment to upcoming trials: “We remain laser focused on our preparation for the initiation of the LUGANO trial, the first pivotal, non-inferiority clinical trial for wet AMD, in the second half of this year,” he stated. The enthusiasm stems from highly positive data observed in earlier studies, which positions DURAVYU as a potential game-changer in maintenance therapy for patients with wet AMD.

Safety Profile and Regulatory Status

DURAVYU has maintained a favorable safety and tolerability profile throughout the trial, with no significant ocular or systemic serious adverse events reported. This includes no observed cases of endophthalmitis or retinal vasculitis, bolstering its profile as a safe treatment option pending further investigation.

The trial, listed on clinicaltrials.gov under identifier NCT05383209, is set to continue providing valuable data with further milestones expected in the coming months, including additional Phase 3 trials.

EyePoint Pharmaceuticals remains dedicated to advancing treatment options for patients with serious retinal diseases, striving to overcome the challenges presented in clinical development to bring innovative solutions to market.