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Duravyu Misses Primary Endpoint in Phase 3 LUGANO for Wet AMD

The vorolanib intravitreal insert reduced treatment burden despite failing to achieve noninferiority in the full analysis.

Retinal Physician August 17, 2026

 

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EyePoint reported top-line results from the phase 3 LUGANO trial of Duravyu (vorolanib intravitreal insert) 2.7 mg in patients with wet age-related macular degeneration (AMD). The study missed its primary endpoint in the full dataset but met several secondary endpoints. The primary endpoint assessed change from baseline in best-corrected visual acuity compared with on-label 2 mg aflibercept. Duravyu did not achieve noninferiority in the full analysis.

EyePoint reported that 9 of 211 Duravyu patients, or 4%, experienced vision loss of at least 15 letters for reasons unrelated to wet AMD, compared with no patients in the aflibercept arm. In an ad hoc analysis excluding those 9 patients, Duravyu was noninferior to aflibercept (nominal P=.0096). Duravyu reduced treatment burden by 42% vs aflibercept through week 56, achieving superiority (nominal P<.0001). The reduction corresponded to an average of 2 fewer injections.

Through week 32, 76% of Duravyu patients required no supplemental injections and 94% received 0 or 1. At week 56, 54% remained supplement free and 79% had received 0 or 1 supplement. A prespecified analysis of supplement-free patients found Duravyu noninferior to aflibercept for change in visual acuity (nominal P=.0035). The mean difference in central subfield thickness between groups was 4 µm at week 56.

“While the primary endpoint result for the full dataset was unexpected, the consistently positive results from the prespecified secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for Duravyu as a new potential therapeutic option for wet AMD," said Jay Duker, MD, president and CEO of EyePoint, in a news release. "We look forward to a potential New Drug Application filing with [the US Food and Drug Administration] in the first half of 2027, pending LUCIA results in the fourth quarter of 2026.”

EyePoint reported no differences in cataracts, elevated intraocular pressure, or intraocular inflammation between groups. Results from the second phase 3 wet AMD trial, LUCIA, are expected in the fourth quarter of 2026.