EyePoint, Inc. has released topline results from LUGANO, the first of two pivotal Phase 3 clinical trials for DURAVYU (vorolanib intravitreal insert) in treating wet age-related macular degeneration (wet AMD). The company, focused on developing therapeutics for retinal diseases, announced that DURAVYU demonstrated non-inferiority to on-label aflibercept in an ad hoc analysis. This analysis excluded a 4% asymmetric cohort of nine out of 211 patients who experienced vision loss of 15 letters or more, unrelated to wet AMD.
The primary endpoint of change from baseline in best corrected visual acuity (BCVA) was not met in the full dataset, which the company attributed to the confounding effect of this asymmetric cohort. In contrast, no patients in the aflibercept control arm experienced vision loss of 15 letters or more unrelated to wet AMD. Prior Phase 3 trials of similar scale indicated that approximately 3-5% of aflibercept patients typically experience such vision loss, suggesting an overperformance by the aflibercept control group in the LUGANO trial.
Despite the primary endpoint outcome in the full dataset, LUGANO showed clinically meaningful results across key secondary endpoints. These included a 42% reduction in treatment burden, achieving superiority over on-label aflibercept with a nominal p-value of less than 0.0001. This reduction translates to an average of two fewer injections for DURAVYU patients compared to on-label aflibercept up to Week 56. Additionally, 76% of DURAVYU patients were supplement-free up to Week 32, and 54% were supplement-free up to Week 56. A pre-specified analysis of BCVA change in supplement-free DURAVYU patients showed non-inferiority to supplement-free aflibercept, with a nominal p-value of 0.0035.
DURAVYU also demonstrated a favorable safety profile with repeat dosing. No differences were observed in cataracts, elevated intraocular pressure, or intraocular inflammation between the study and control groups. There were no occurrences of insert migration, anterior chamber opacities, free-floating drug particles, retinal vasculitis, or severe intraocular inflammation. Strong anatomic control was maintained through Week 56, with a mean difference of 4 microns versus on-label aflibercept control in central subfield thickness (CST) at Week 56.
Jay S. Duker, M.D., President and CEO of EyePoint, stated that the outstanding outcomes across key secondary endpoints, combined with visual improvement, reinforce confidence in DURAVYU’s potential to transform the current wet AMD treatment paradigm. Carl D. Regillo, M.D., FACS, Former Director of the Wills Eye Hospital Retina Service, noted that nearly 80% of DURAVYU-treated patients received one or no supplemental injections through Week 56, indicating a meaningful reduction in treatment burden. Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint, highlighted the durable efficacy and stable retinal anatomy maintained through Week 56, avoiding the sawtooth pattern often seen with intermittent anti-VEGF therapy.
EyePoint expects topline data from LUCIA, the second pivotal Phase 3 clinical trial in wet AMD, in the fourth quarter of 2026. Pending these results, a New Drug Application (NDA) submission to the FDA is planned for the first half of 2027. The company also reported that pivotal Phase 3 COMO and CAPRI clinical trials for DURAVYU in diabetic macular edema (DME) have completed enrollment, with topline data anticipated in the fourth quarter of 2027.