EyePoint receives second consecutive positive recommendation from DSMC

The Data Safety Monitoring Committee (DSMC) recently completed its second scheduled review of EyePoint Pharmaceuticals’ ongoing phase 3 trial evaluating DURAVYU for the treatment of wet AMD (wAMD), EyePoint announced.¹ The DSMC concluded that both the LUGANO and LUCIA trials continue as planned, “with no modifications to the protocol,” said EyePoint in a press release.¹

The ongoing phase 3 program includes both the LUGANO and LUCIA trials—both of which are identical pivotal noninferiority trials. In July, EyePoint announced it completed enrollment of both trials, including the enrollment and random assignment of more than 400 patients of the LUCIA trial in 7 months, making DURAVYU one of the fastest enrolling phase 3 programs in wAMD.²

“We are pleased to receive our second consecutive positive recommendation from the DSMC for our pivotal wet AMD program. Now that all patients are past initial dosing and a growing number have received redosing, this recommendation strengthens our confidence in DURAVYU’s consistent, favorable safety profile observed across its robust development history,” Ramiro Ribeiro, MD, PhD, Chief Medical Officer at EyePoint, said in a press release.¹

The DSMC reviewed data as part of the September 29, 2025, data cutoff, which showed all patients across LUGANO and LUCIA received their initial dose of DURAVYU at week 8, followed by around 25% of patients receiving their second planned DURAVYU dose at week 32.¹ The phase 3 trials are the only sustained-release wAMD phase 3 trials evaluating the safety and efficacy of DURAVYU, delivered via intravitreal injection, for the treatment of wAMD.^1,2

The LUGANO and LUCIA trials, with more than 900 patients enrolled between the two, are the only phase 3 trials evaluating 6-month redosing of DURAVYU over two years. The treatment is administered similarly to already-approved anti-VEGF treatments, with patients receiving an intravitreal injection in their physician’s office.

The primary endpoint is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline.¹ Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results measured by OCT.¹

“With its use of a noninferiority design and on-label aflibercept control, EyePoint’s phase 3 program is designed to generate data relevant to practitioners like myself,” Anat Loewenstein, MD, MHA, vice president of ambulatory services, head of retina at Tel Aviv Medical Center, president of the European Society of Retina Specialists, and a member of EyePoint’s scientific advisory board, said in a press release earlier this year.²

“Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved [adherence] 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.”

References:

• EyePoint Pharmaceuticals, Inc. EyePoint Announces Positive Recommendation from Independent Data Safety Monitoring Committee for Pivotal Phase 3 Trials for DURAVYU^TM in Wet Age-Related Macular Degeneration. GlobeNewswire News Room. Published November 19, 2025. Accessed November 19, 2025. https://www.globenewswire.com/news-release/2025/11/19/3190786/0/en/EyePoint-Announces-Positive-Recommendation-from-Independent-Data-Safety-Monitoring-Committee-for-Pivotal-Phase-3-Trials-for-DURAVYU-in-Wet-Age-Related-Macular-Degeneration.html
• Filkins K. EyePoint completes enrollment of LUGANO and LUCIA trials. Modernretina.com. Published July 30, 2025. Accessed November 19, 2025. https://www.modernretina.com/view/eyepoint-completes-enrollment-of-lugano-and-lucia-trials