Key Takeaways

• LUCIA did not achieve the primary endpoint of statistical noninferiority in mean change in BCVA versus on-label aflibercept (Eylea, Regeneron) control, despite demonstrating visual improvement.
• Key secondary endpoints in LUCIA were met including a superior 38% reduction in treatment burden (nominal p-value <0.0001), with 52% of eyes supplement-free and 71% receiving zero or one supplement up to Week 56.
• Diabetic macular edema program remains on track with phase 3 topline data anticipated in late 2027.

EyePoint announced topline results from LUCIA, the second pivotal phase 3 clinical trial of vorolanib intravitreal insert (Duravyu) for the treatment of wet AMD. In the trial, treatment with vorolanib did not achieve statistical noninferiority in mean change in BCVA versus on-label aflibercept 2 mg (Eylea, Regeneron) control, although it demonstrated visual improvement. The trial achieved key secondary endpoints including a favorable safety profile with redosing, a 38% reduction in treatment burden, a 52% supplement-free rate, 71% receiving zero or one supplement up to 56 weeks, and strong anatomic control.

EyePoint will complete additional analyses of the LUCIA and pooled phase 3 datasets to further assess next steps for DURAVYU as a potential treatment for wet AMD.

The Company continues to advance the ongoing pivotal COMO and CAPRI clinical trials for patients with diabetic macular edema (DME), with topline data expected in the fourth quarter of 2027. The phase 2 VERONA clinical trial in DME met its primary endpoint with extended time to first supplemental injection compared with aflibercept control for both doses. The trial also produced clinically meaningful outcomes, including a favorable safety profile with no vorolanib-related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. Vorolanib 2.7 mg demonstrated a 7.1 letter BCVA gain and 76-μm central subfield thickness reduction at 24 weeks, with a supplement-free rate of 73% versus 50% for patients in the control arm.

“We are encouraged that more than 50% of Duravyu patients remained supplement-free up to 56 weeks in both phase 3 trials, providing further evidence of DURAVYU’s durability in retinal disease,” said Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint. “We remain confident in the DME program, supported by Duravyu’s biologic activity through inhibition of VEGF and the IL-6/JAK1 pathway, its continued favorable safety profile, and the early visual and anatomic improvements observed in VERONA.”