EyePoint Pharmaceuticals announced that its independent Data Safety Monitoring Committee (DSMC) has completed its second scheduled review of the pivotal Phase 3 trials—named LUGANO and LUCIA—evaluating DURAVYU for the treatment of wet age-related macular degeneration (wet AMD). The committee recommended that both trials continue as planned with no protocol changes, reflecting confidence in the safety profile of the therapy. The milestone covers the status as of the data cut-off date of September 29, 2025, when all patients had reached Week 8 post-initial dosing and approximately 25 % had received their second scheduled dose at Week 32.
The two trials are designed to compare DURAVYU, a six-month sustained-release intravitreal insert containing vorolanib, against the standard on-label control therapy (aflibercept). LUGANO and LUCIA are fully enrolled (over 900 patients combined), include both treatment-naïve and treatment-experienced patients, and fit a non-inferiority design assessing best corrected visual acuity (BCVA) at Weeks 52 and 56 as the primary endpoint. Secondary endpoints include the percentage of eyes free of supplemental injections, anatomical changes via OCT (optical coherence tomography), and reduction in treatment burden.
The DSMC review found no new safety signals. EyePoint emphasised that this strengthens its confidence in DURAVYU’s consistent favourable safety experience across prior Phase 1/2 studies. The company noted that topline 56-week data from the LUGANO trial are expected in mid-2026, with LUCIA results shortly after.
For investors and stakeholders, the DSMC recommendation is a meaningful operational milestone: it clears a major hurdle in the pivotal programme and reduces near-term regulatory uncertainty. That said, the data remain blinded, and efficacy outcomes will be the next key inflection point. The company also remains subject to the broader risks of a developmental therapy in retinal disease, including manufacturing scale-up, regulatory review and commercial reimbursement.
In summary, EyePoint’s DURAVYU pivotal programme has passed a critical safety review, enabling it to proceed on schedule toward anticipated mid-2026 topline data in a sustained-release therapy for wet AMD.
