Запись из первоисточника
РешающееПредварительные результаты
EYPT: топлайн-данные фазы 3 LUGANO по DURAVYU при влажной форме ВМД (wet AMD)
LUGANO topline showed DURAVYU did not meet the pre-specified non-inferiority endpoint for BCVA change versus aflibercept in the full dataset, although a nominal p-value of 0.0096 was achieved after excluding an asymmetric cohort of 9 patients who lost ≥15 letters from non-wet AMD causes. The company still plans to submit an NDA for wet AMD in the first half of 2027 and expects the LUCIA Phase 3 readout in Q4 2026.
Ключевые факты
- Подано
- 10 сент. 2026 г., 11:05
- Событие
- Предварительные результаты
- Направление
- Отрицательное
- Компания
EYPTEyePoint- Актив
- vorolanib
- Источник
- SEC 8-K
- Достоверность
- Подтверждено
- enrollment time
- five months
- enrolled patients
- over 480
Выдержка из источника
EX-99.1 2 eypt-ex99_1.htm EX-99.1 LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses | September 2026 Exhibit 99.1 Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, are forward-looking statements, including but not limited to statements regarding: our expectations regarding our clinical development and regulatory plans, including the submission of a potential FDA New Drug Application for DURAVYU™ for the potential treatment of wet AMD
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