EyePoint Pharmaceuticals falls short of primary endpoint for Phase 2 PAVIA Trial for NPDR
Conditionally accepted by the FDA as EYO-1901, DURAVYU is a tyrosine kinase inhibitor intended to improve signs and symptoms of non-proliferative diabetic retinopathy in the PAVIA trial.
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EyePoint Pharmaceuticals announced that its Phase 2 PAVIA trial fell short of achieving its primary endpoint of improvement of non-proliferative diabetic retinopathy (NPDR) of at least 2 Diabetic Retinopathy Severity Scale (DRSS) levels as of week 36, or approximately 9 months, after the DURAVYU injection. However, EyePoint did report that DURAVYU demonstrated stable or improved disease severity with reduced rates of NPDR in 9 months, as well as displayed a favorable safety and tolerability profile with no drug-related serious adverse events, according to a release. Additionally, no cases of endophthalmitis or retinal vasculitis were observed.1
DURAVYU, previously known as and conditionally accepted by the FDA as EYO-1901, is a tyrosine kinase inhibitor and was administered to study participants in 2 doses as an intravitreal insert in the multicenter, prospective, double-masked, parallel trial.1,2 FDA approval, along with its timeline for potential approval, is uncertain at this time, the release said.
“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.”
The PAVIA trial assessed 77 patients with moderately-severe to severe NPDR for 12 months, who were randomly assigned 1 of 2 doses of DURAVYU, or a sham injection in the control group. The injection is administered in a similar fashion to current FDA approved anti-VEGF treatments, according to the release. In the study, 86% of patients in the 3mg arm and 80% of patients in the 2mg arm experienced stable or improved disease at 9 months versus 70% in the control arm.1
Additionally, no patients in the 3mg arm and 80% of patients in the 2mg arm worsened ≥2-step at 9 months compared to 10% in the control arm. However, 5% of patients in the 3mg arm and 0% of patients in the 2mg arm achieved a ≥2-step improvement in DRSS score at 9 months versus 5% in the control arm.1
Secondary endpoints of the study include reduction in vision-threatening complications, occurrence of diabetic macular edema (DME) and/or proliferative disease, retinal ischemia/nonperfusion, and safety.1
“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,” Duker said in the release. “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.”
EyePoint is also anticipating initiations and topline results from several other trials assessing DURAVYU’s efficacy. The Phase 3 LUGANO pivotal trial is will assess DURAVYU in wet age-related macular degeneration (AMD), with initiation anticipated in the second half of 2024, with a second global Phase 3 pivotal trial LUCIA for wet AMD to follow. Topline data from the Phase 2 VERONA trial in DME is expected in the first quarter of 2025.1
References:
EyePoint Pharmaceuticals announces topline data from the Phase 2 PAVIA trial of DURABYU in non-proliferative diabetic retinopathy. News release. EyePoint Pharmaceuticals. May 6, 2024. Accessed May 7, 2024. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-announces-topline-data-phase-2-pavia
EyePoint Pharmaceuticals, Inc. Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR). ClinicalTrials.gov. NCT05383209. Updated February 12, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT05383209?id=NCT05383209&rank=1
