Key Takeaways

  • EyePoint has completed enrollment ahead of schedule in the global phase 3 COMO and CAPRI trials evaluating Duravyu for DME, with more than 480 patients enrolled in 5 months
  • The studies will compare 6-month dosing of Duravyu with on-label aflibercept, with topline efficacy and safety data expected in the fourth quarter of 2027

EyePoint Pharmaceuticals has completed patient enrollment in its two global phase 3 clinical trials evaluating Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME), reaching a key development milestone ahead of schedule.

The company announced that more than 480 patients have been enrolled across the COMO and CAPRI studies, with full enrollment completed in 5 months. Topline results from both pivotal trials are expected in the fourth quarter of 2027.

"Completing enrollment across both COMO and CAPRI ahead of expectations is a testament to our team's exceptional execution and dedication to delivering a potentially more durable and differentiated treatment option for patients with DME, the second largest retinal disease market," said Jay S. Duker, MD, president and chief executive officer of EyePoint. "Duravyu's compelling efficacy and safety profile, combined with positive feedback on our trial design from both the FDA and EMA, underscores our confidence in the program as we advance toward topline data in DME anticipated next year."

COMO and CAPRI are global, randomized, double-masked, active-controlled, noninferiority phase 3 studies comparing a 2.7 mg intravitreal insert of Duravyu with on-label 2 mg aflibercept in patients with DME. The trials include both treatment-naïve and previously treated patients.

Participants are randomized to receive either Duravyu or aflibercept on Day 1. Patients assigned to Duravyu are scheduled for repeat dosing every 6 months through a standard intravitreal injection administered in the physician's office.

The primary endpoint is noninferior change from baseline in best corrected visual acuity (BCVA), assessed as the blended average of weeks 52 and 56, compared with aflibercept. Secondary endpoints include safety, reduction in treatment burden, the proportion of eyes requiring no supplemental aflibercept injections, and anatomical outcomes measured by optical coherence tomography (OCT).

According to EyePoint, the phase 3 program was designed based on results from the phase 2 VERONA trial, in which Duravyu 2.7 mg demonstrated early and sustained improvements in BCVA, a two-thirds reduction in treatment burden, prolonged time to first supplemental injection compared with aflibercept, and improvements in central subfield thickness.

The company said the phase 3 development program was developed in alignment with both the FDA and the European Medicines Agency (EMA).

In May 2026, an independent Data Safety Monitoring Committee reviewed masked safety data from the company's ongoing phase 3 wet age-related macular degeneration and DME programs and recommended that both studies continue without protocol modifications. EyePoint reported that Duravyu has now been evaluated in more than 190 patients across four completed clinical trials, with no Duravyu-related safety concerns observed.