EyePoint completes enrollment of LUGANO and LUCIA trials

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EyePoint Pharmaceuticals recently announced the completion of enrollment for its phase 3 LUCIA trial.¹

The second of two identical ongoing pivotal noninferiority trials, the LUCIA trial is for the evaluation of DURAVYU for the treatment of wet age-related macular degeneration (AMD). The first trial, LUGANO, completed enrollment in May 2025. LUCIA has enrolled and randomized more than 400 patients in 7 months, which makes DURAVYU one of the fastest enrolling phase 3 pivotal programs in wet AMD.

“The rapid enrollment of the LUCIA trial reflects its patient-centric design, DURAVYU’s excellent safety profile, and EyePoint’s ongoing engagement with the retinal community,” Anat Loewenstein, MD, MHA, Vice President Ambulatory Services, Head of Retina Tel Aviv Medical Center, President of European Society of Retina Specialists, and member of EyePoint’s Scientific Advisory Board, said in a press release.¹

“With its use of a noninferiority design and on-label aflibercept control, EyePoint’s phase 3 program is designed to generate data that is relevant to clinical practitioners like myself. Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved compliance for patients, representing a potential paradigm shift for the treatment of wet AMD. It is my pleasure to contribute to this cutting-edge research, which holds the promise of improving outcomes for retinal disease patients worldwide.”

Safety and efficacy data from the DAVIO 2 phase 2 clinical trial supports both LUGANO and LUCIA. The phase 3 pivotal program was developed in alignment with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

LUGANO and LUCIA are randomized, double-masked, aflibercept-controlled, noninferiority phase 3 trials for the evaluation of DURAVYU’s safety and efficacy for the treatment of wet AMD—including both naïve and treatment-experienced patients. Randomized 1:1, patients either receive DURAVYU 2.7mg treatment or an on-label aflibercept control.

Randomized on day one, all patients immediately begin treatment with a one-year efficacy and safety endpoint to support the NDA filing, a press release said.¹ Topline data of LUGANO is expected mid-2026, followed shortly after by LUCIA. DURAVYU is delivered via intravitreal injection.

“With enrollment now complete for our phase 3 wet AMD program, well ahead of our expectations, we continue to demonstrate exceptional execution and our deep commitment to the retinal disease community,” Jay S. Duker, MD, president and chief executive officer of EyePoint, said in a press release.

“The industry-leading pace of our clinical program is a testament to the patient and physician enthusiasm for innovative, novel, and more durable wet AMD treatments and DURAVYU’s compelling and differentiated profile. As we look ahead to anticipated topline data for LUGANO in mid-2026 and LUCIA to follow, we remain focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”

Reference:

1. EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU^TM in Wet Age-Related Macular Degeneration - EyePoint Pharmaceuticals. EyePoint Pharmaceuticals. Published 2025. Accessed July 29, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-trials-duravyutm