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:

• EyePoint Pharmaceuticals