EyePoint Pharmaceuticals, Inc. announced topline results of its phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR).
The data demonstrated that DURAVYU has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint. The company plans to provide an update on the path forward for DURAVYU as a potential treatment in NPDR following a review of the full 12-month data.
“The objective of the PAVIA trial was, for the first time, to evaluate DURAVYU as a potential treatment in a non-proliferative diabetic patient population,” said Jay Duker, MD, CEO of EyePoint Pharmaceuticals. “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. We plan to analyze the full twelve-month data once it is available to gain the clarity needed to assess the future of DURAVYU as a potential treatment for NPDR. I would like to thank the patients, the investigators and their site staff who participated in the PAVIA trial. We look forward to providing additional clinical and regulatory updates on the NPDR program in the coming months.”
Dr. Duker continued, “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. We remain confident that DURAVYU has the potential to change the treatment paradigm as a maintenance therapy for wet AMD patients based on the highly positive data seen in DAVIO 2, the largest intravitreal sustained release TKI study in wet AMD to date.”
PAVIA topline interim results include:
- 86% of patients in the 3mg arm and 80% of patients in the 2mg arm demonstrated stable or improved disease at nine months versus 70% in the control arm.
- 0% of patients in the 3mg arm and 5% of patients in the 2mg arm worsened ≥2-step at nine months vs. 10% in the control arm.
- 5% of patients in the 3mg arm and 0% of patients in the 2mg arm achieved a ≥2-step improvement in DRSS score at nine months versus 5% in the control arm.
- Continued favorable safety and tolerability profile with no DURAVYU-related ocular or systemic serious adverse events reported.
- No cases of endophthalmitis or retinal vasculitis (occlusive or non-occlusive) were observed.
PAVIA is a 12-month, randomized, controlled phase 2 clinical trial of DURAVYU in patients with moderately-severe to severe NPDR. The trial enrolled 77 patients randomly assigned to one of two doses of DURAVYU, or to the control group receiving a sham injection. DURAVYU is delivered with a routine intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the trial is improvement of at least two DRSS levels as of week 36 (approximately nine months) after the DURAVYU 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).
The company remains on track to reach additional clinical milestones with DURAVYU with the initiation of the first phase 3 pivotal trial in wet AMD, LUGANO, anticipated in the second half of 2024 and the second global phase 3 pivotal trial in wet AMD, LUCIA, to follow, and with the readout of topline data from the phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2025.
DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.