Vorolanib Insert Misses Noninferiority vs Aflibercept in Second Wet AMD Trial

The investigational vorolanib intravitreal insert (Duravyu, EyePoint) did not meet its primary endpoint of noninferiority to aflibercept for mean change in best-corrected visual acuity (BCVA) in LUCIA, the second of 2 pivotal phase 3 trials in wet age-related macular degeneration (AMD), EyePoint announced. The first trial, LUGANO, also did not meet its primary endpoint in its full dataset.

Vorolanib is a tyrosine kinase inhibitor delivered in a bioerodible insert designed to release drug for at least 6 months, according to the company. LUCIA and LUGANO are identical randomized, double-masked, aflibercept-controlled noninferiority trials in treatment-naive and treatment-experienced patients with active wet AMD; LUCIA enrolled 475 patients and LUGANO 432. Patients were randomized 1:1 to the vorolanib insert 2.7mg every 24 weeks or on-label aflibercept 2mg every 8 weeks, with supplemental aflibercept as needed under prespecified criteria. The primary endpoint was mean change in BCVA from baseline at blended weeks 52 and 56.

EyePoint said the insert demonstrated visual improvement but did not report BCVA results in its announcement. In LUCIA, the insert met key secondary endpoints, according to the company, including a 38% reduction in treatment burden (nominal P < 0.0001); 52% of eyes needed no supplemental injection and 71% received 0 or 1 supplement through week 56. LUGANO showed a 42% reduction in treatment burden (nominal P < 0.0001).

The company described the safety profile with redosing as favorable but did not include adverse event data. It also reported anatomic control at week 56 without releasing anatomic measurements.

EyePoint said it will complete additional analyses of LUCIA and the pooled phase 3 data to assess next steps in wet AMD. The insert has not been approved by the FDA and is being evaluated in the phase 3 COMO and CAPRI trials in diabetic macular edema, with topline data expected in the fourth quarter of 2027.

Source: EyePoint. EyePoint announces topline results from LUCIA, the second pivotal phase 3 clinical trial of Duravyu in wet AMD. News release. EyePoint; October 19, 2026. Accessed October 19, 2026.