A 4% anomaly turned a pivotal win into an endpoint miss

The pivotal success bar was not cleared. LUGANO’s primary endpoint—non-inferiority in vision change versus on-label aflibercept—was not achieved in the full dataset, which is the result that matters most for regulatory credibility. 〔0〕

The failure appears concentrated in an unusual imbalance, but the rescue analysis is post hoc. Nine of 211 DURAVYU patients experienced unrelated vision loss of at least 15 letters, while none did in the control arm; excluding that 4% cohort produced nominal non-inferiority. That makes the result potentially explainable, but investors and regulators will still treat the full-dataset miss as a material qualification rather than a clean win. 〔1〕

The durability profile is genuinely strong and preserves the commercial thesis. DURAVYU cut treatment burden by 42%, equivalent to two fewer injections on average through Week 56, while 54% of patients remained supplement-free and 79% needed zero or one supplemental injection. Those outcomes support the six-month dosing proposition, but they do not fully offset missing the principal vision endpoint. 〔2〕

The program now depends heavily on replication in LUCIA. Management still expects the second identical Phase 3 trial to report in Q4 2026 and potentially supports an NDA filing in the first half of 2027. The next trial must show that the LUGANO result was an isolated statistical imbalance—not a sign that the efficacy margin is less robust than expected. 〔3〕