New Data for Bioerodible DURAVYU in Wet AMD - Summary - MDSpire
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New Data for Bioerodible DURAVYU in Wet AMD

  • September 17, 2026

  • 5 min

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Objective:

To evaluate the efficacy and safety of DURAVYU (EYP-1901) in comparison to aflibercept in patients with wet AMD.

Approach:
  • Trial Design: The LUGANO trial was a randomized, double-masked Phase 3 study comparing DURAVYU 2.7 mg to aflibercept 2 mg every 8 weeks.
  • Primary Endpoint: The primary endpoint was the mean change in best-corrected visual acuity (BCVA), which was not met in the full dataset.
  • Secondary Endpoints: Key secondary endpoints showed strong anatomic control, durability, and reduced treatment burden.
Key Findings:
  • Mean vision improved in the full DURAVYU cohort despite not meeting the primary endpoint.
  • Nine patients in the DURAVYU group experienced ≥15-letter vision loss from causes not related to neovascular AMD.
  • DURAVYU demonstrated a 42% reduction in treatment burden compared to aflibercept.
  • 76% of DURAVYU-treated patients remained supplement-free at Week 32.
Interpretation:

The unexpected imbalance in vision loss among a small subset of patients affected the primary endpoint results.

Limitations:
  • The primary endpoint was not met in the full analysis set.
  • The results were influenced by an imbalance in vision loss cases.
Conclusion:

The results of the LUGANO trial indicate the need for further validation in the upcoming LUCIA trial.

Sources:

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