EyePoint, Inc., a company committed to developing and commercialising innovative therapeutics to improve the lives of patients with serious retinal diseases, has completed enrolment in two global phase 3 clinical trials of Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular oedema (DME).
Over 480 patients have been enrolled across both trials, with full enrolment occurring ahead of schedule, in only five months. Topline data for both DME trials are anticipated in the fourth quarter of 2027.
COMO and CAPRI are global, randomised, double-masked, on-label 2mg aflibercept controlled non-inferiority phase 3 trials assessing the safety and efficacy of Duravyu in DME, and include both treatment-naïve and previously treated patients.Patients are randomised on day 1 to a Duravyu 2.7mg dose arm or the aflibercept control arm. Patients in the Duravyu arm will be re-dosed every six months.
Duravyu is delivered via a single standard intravitreal injection in the physician’s office, similar to current FDA approved intravitreal treatments.
primary endpoint is a non-inferior change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended, compared to on-label 2mg aflibercept control. Secondary endpoints include safety, superiority in reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).
In May 2026, an independent Data Safety Monitoring Committee (DSMC) convened to review masked safety data from Duravyu’s ongoing phase 3 programmes in wet age-related macular degeneration (wet AMD) and DME. Upon completion of its review, the DSMC recommended continuation of both programmes as planned, with no protocol modifications.
Duravyu has been evaluated in over 190 patients across four completed clinical trials, demonstrating a favourable safety and tolerability profile including no observed DURAVYU-related safety concerns.
