EyePoint Pharmaceuticals has completed enrollment in its 2 global phase 3 clinical trials evaluating Duravyu (vorolanib intravitreal insert) for diabetic macular edema (DME), reaching the milestone ahead of schedule after enrolling more than 480 patients across the COMO and CAPRI studies. The company said topline results from both trials are expected in the fourth quarter of 2027.

The randomized, double-masked, noninferiority studies compare Duravyu 2.7 mg, administered every 6 months by intravitreal injection, with on-label aflibercept 2 mg (Eylea; Regeneron) in both treatment-naïve and previously treated patients with DME. The primary endpoint is the blended change in best-corrected visual acuity at weeks 52 and 56. Secondary endpoints include safety, reduction in treatment burden, the proportion of eyes requiring no supplemental aflibercept injections, and optical coherence tomography outcomes.

According to EyePoint, the phase 3 program was designed in alignment with feedback from both the US Food and Drug Administration (FDA) and the European Medicines Agency. In May, an independent Data Safety Monitoring Committee reviewed masked safety data from the company's ongoing phase 3 DME and neovascular age-related macular degeneration programs (LUGANO and LUCIA) and recommended that both continue without protocol modifications.

The DME pivotal trials build on findings from the phase 2 VERONA study, in which Duravyu demonstrated improvements in visual acuity and central subfield thickness, reduced treatment burden, and prolonged time to supplemental aflibercept injection compared with aflibercept control. Duravyu combines pan-VEGF receptor inhibition with IL-6/JAK1 pathway inhibition and has been evaluated in more than 190 patients across 4 completed clinical studies, according to the company. RP