EyePoint (Watertown, MA) has announced that it has completed enrollment in two pivotal Phase 3 trials evaluating DURAVYUTM, its sustained-delivery treatment for diabetic macular edema (DME).
The global COMO and CAPRI studies enrolled more than 480 patients in five months, reaching full enrollment ahead of schedule. EyePoint expects to report topline 56-week data from both studies in the fourth quarter of 2027.
DURAVYU (vorolanib intravitreal insert) is designed to release treatment inside the eye for at least six months. It combines the tyrosine kinase inhibitor vorolanib with EyePoint’s bioerodible Durasert E drug-delivery technology.
COMO and CAPRI are randomized, double-masked, non-inferiority studies comparing a 2.7mg dose of DURAVYU with on-label 2mg aflibercept. The trials include both previously treated patients and people who have not received treatment for DME.
Participants assigned to DURAVYU will be re-dosed every six months. The primary endpoint will assess whether the treatment is non-inferior to aflibercept in the change from baseline in best-corrected visual acuity, using a blended measurement from weeks 52 and 56.
Secondary measures include safety, reductions in treatment burden, the proportion of eyes requiring no supplemental aflibercept injections and anatomical changes measured using optical coherence tomography.
EyePoint said the Phase 3 program was informed by results from the Phase 2 VERONA trial. In that study, the 2.7mg dose of DURAVYU produced early and sustained improvements in vision and retinal anatomy while reducing treatment burden by approximately two-thirds. Patients receiving DURAVYU also went longer before requiring a supplemental injection than those in the aflibercept control group.
DURAVYU is designed to inhibit all VEGF receptors and platelet-derived growth factor receptors while also targeting inflammation through IL-6/JAK1 signalling. EyePoint believes this multi-mechanism approach could address several biological drivers of DME rather than VEGF-mediated leakage alone.
The company is also evaluating DURAVYU in two fully enrolled Phase 3 trials for wet age-related macular degeneration.
