EyePoint Pharmaceuticals said that the Phase 2 PAVIA clinical trial evaluating Duravyu (vorolanib intravitreal insert) in patients with non-proliferative diabetic retinopathy (NPDR) failed to meet the primary endpoint.
Duravyu, previously known as EYP-1901, is being developed as a potential paradigm-altering therapy for individuals with VEGF-mediated retinal diseases.
The candidate is currently in three ongoing Phase 2 studies in wet age-related macular degeneration (wet AMD), NPDR, and diabetic macular edema (DME).
The, randomised, controlled Phase 2 PAVIA trial assessed Duravyu in 77 patients with moderately severe to severe NPDR for 12 months.
It randomised patients to one of two doses of the therapy, or to the control group getting a sham injection.
PAVIA’s primary efficacy endpoint was defined as an improvement of at least two Diabetic Retinopathy Severity Scale (DRSS) levels as of week 36 after the Duravyu injection.
According to the results, the investigational treatment showed a biological effect in patients with NPDR with a favourable safety and tolerability profile but did not meet the pre-specified primary endpoint.
At nine months, 86% of patients receiving 3mg and 80% receiving 2mg showed stable or improved disease, compared to 70% in the control group.
A deterioration by ≥2 steps in DRSS score was observed in 0% and 5% of patients in the 3mg and 2mg arms respectively, versus 10% in the control group.
Additionally, 5% of patients in the 3mg arm experienced a ≥2-step enhancement in the DRSS score, contrasting with 0% in the 2mg arm and 5% in the control arm.
Furthermore, there were no reported serious adverse events, maintaining the therapy’s favourable safety and tolerability profile.
EyePoint Pharmaceuticals plans to provide an update on the future direction of Duravyu for NPDR following a thorough examination of the complete 12-month dataset.
EyePoint Pharmaceuticals CEO Jay Duker 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.
“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.”
The company will start the first Phase 3 LUGANO trial in wet AMD in the latter half of 2024, followed by the second global Phase 3 LUCIA trial in wet AMD.
