LUCIA Misses Duravyu BCVA Noninferiority Endpoint in Wet AMD

Key Takeaways

• In patients with wet age-related macular degeneration (wet AMD), phase 3 LUCIA missed the Duravyu visual-acuity noninferiority endpoint versus aflibercept despite reported visual improvement.
• EyePoint reported a nominally significant reduction in treatment burden and less need for supplemental treatment, distinct from the missed visual-acuity endpoint.
• EyePoint characterized redosing safety as favorable and anatomic control as strong, without providing numerical support for those descriptions in the topline account.

For patients with wet age-related macular degeneration (wet AMD), maintaining vision while limiting repeated intravitreal treatment remains a clinical challenge. The vorolanib intravitreal insert (Duravyu) is being evaluated against aflibercept in this setting. In LUCIA, investigators assessed comparative visual acuity and the need for supplemental treatment.

EyePoint's LUCIA is the second pivotal phase 3 trial of the vorolanib intravitreal insert in wet AMD. It compared Duravyu with on-label aflibercept 2 mg, with statistical noninferiority for mean change in best-corrected visual acuity (BCVA) as its primary endpoint.

Statistical noninferiority for mean BCVA change versus on-label aflibercept was not established in the LUCIA phase 3 topline findings for Duravyu in wet AMD, although EyePoint reported visual improvement. EyePoint separately reported a 38% reduction in treatment burden, with a nominal p<0.0001, as a secondary finding.

Through week 56, EyePoint reported that 52% of eyes remained supplement-free and 71% received zero or one supplement. EyePoint also characterized safety with redosing as favorable and anatomic control as strong.

EyePoint said it plans further analysis of LUCIA and pooled phase 3 data to assess the next steps for Duravyu in wet AMD.

Clinician Questions

What did the VERONA trial show for Duravyu in diabetic macular edema?

EyePoint reported that phase 2 VERONA in DME met its primary endpoint: time to first supplemental injection was longer than with aflibercept control at both vorolanib doses. EyePoint described no vorolanib-related ocular or systemic serious adverse events in VERONA.

When are results expected from the COMO and CAPRI Duravyu trials in diabetic macular edema?

EyePoint expects topline findings from its ongoing pivotal phase 3 COMO and CAPRI trials in DME in the fourth quarter of 2027.

Recommended Reading

• For more on intravitreal TKIs versus aflibercept in wet AMD: Redefining Durability in Wet AMD: Insights from the SOL‑1 Superiority Trial
• For more on TKI pathways in nAMD care: Treating Outside the Box: New Pathways to Retinal Vascular Stability