EyePoint announced today that in the LUCIA trial, Duravyu (vorolanib intravitreal insert; EYP-1901) failed to meet its primary endpoint of noninferiority to aflibercept 2 mg (Eylea; Regeneron) in patients with neovascular age-related macular degeneration (nAMD). Following this failure of the company’s second pivotal phase 3 trial, EyePoint announced plans to reduce its workforce by approximately 53%, terminate its nAMD trial program, and prioritize development of Duravyu in diabetic macular edema (DME).
The LUCIA trial enrolled 475 patients randomized to receive Duravyu 2.7 mg every 24 weeks or aflibercept 2 mg every 8 weeks, with supplemental aflibercept administered as needed. The primary endpoint was noninferiority in the average change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56.
Although Duravyu demonstrated visual improvement, it did not achieve noninferiority to aflibercept. However, the trial met key secondary endpoints, including a 38% reduction in treatment burden (nominal P<.0001). Through week 56, 52% of Duravyu-treated eyes required no supplemental injections, while 71% received no more than 1 supplement. EyePoint also reported anatomic disease control and a favorable safety profile with redosing.
The results follow those of the companion phase 3 LUGANO trial, which enrolled 432 patients and also failed to demonstrate noninferiority to aflibercept. In that study, Duravyu reduced treatment burden by 42%, with more than half of treated eyes remaining supplement-free through week 56.
Together, the trials enrolled more than 900 patients and were intended to support regulatory approval of Duravyu for nAMD. EyePoint plans to terminate both trials early, without completing their originally planned second year of follow-up. The company said it would conduct additional analyses of the individual and pooled datasets to determine potential next steps for the indication.
The company also announced a restructuring expected to reduce annual operating expenses by approximately $30 million. Most workforce reductions are expected to occur during the fourth quarter of 2026.
EyePoint will instead concentrate resources on the ongoing phase 3 COMO and CAPRI trials evaluating Duravyu in DME. The program follows positive results from the phase 2 VERONA trial, which met its primary endpoint of extending the time to first supplemental injection compared with aflibercept.
In VERONA, Duravyu 2.7 mg produced a mean BCVA gain of 7.1 letters and a 76-µm reduction in central subfield thickness at week 24. The supplement-free rate was 73%, compared with 50% in the aflibercept control group.
Topline results from COMO and CAPRI are expected in the fourth quarter of 2027.