EyePoint Pharmaceuticals has completed enrollment in its Phase 3 LUCIA trial of DURAVYU (vorolanib intravitreal insert) for wet age-related macular degeneration (wet AMD). This follows the May 2025 completion of LUGANO, the program’s first pivotal trial. Together, LUGANO and LUCIA comprise over 800 patients, marking a rapid enrollment pace for a wet AMD program. An interim safety analysis by an independent Data Safety Monitoring Committee (DSMC) found no need for protocol changes.
This milestone reflects EyePoint’s strategy to accelerate timelines and capitalize on unmet needs in the wet AMD treatment landscape. The speed suggests strong physician and patient interest in potential alternatives to the current frequent injection regimens, particularly given DURAVYU’s sustained-release profile aiming for six-month dosing intervals. The company is directly challenging the treatment burden associated with current anti-VEGF therapies, which require more frequent administration.
This fast enrollment has implications for both trial execution and potential market uptake. For EyePoint, it positions the company for a faster path to potential regulatory submission, assuming positive results. For clinicians and patients, it signals the demand for less frequent injections and potentially improved compliance, which could translate to better long-term visual outcomes. This also allows EyePoint to gather substantial safety and efficacy data across a wider patient population.
The trial design itself reflects a broader industry shift toward patient-centricity and real-world evidence generation. The non-inferiority design against the established standard of care, aflibercept, aims to provide data directly relevant to clinical practice. This approach could facilitate smoother market access and payer negotiations, should DURAVYU receive regulatory approval.
Looking forward, topline 56-week data from LUGANO is anticipated in mid-2026, with LUCIA’s results following soon after. The key question remains whether DURAVYU can demonstrate non-inferiority to aflibercept while maintaining its six-month dosing schedule. The upcoming data will be crucial in assessing the durability of the treatment effect and confirming the projected reduction in treatment burden. EyePoint’s success hinges on these results, as they will determine the drug’s competitiveness in a market increasingly crowded with treatment options. Further challenges include potential manufacturing scale-up and commercialization strategies in a competitive landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
