1차 출처 기록
결정급보완요구서한 (CRL)
Aldeyra, 건성안 치료 reproxalap NDA에 대해 FDA CRL 수령
FDA는 NDA가 건성안 질환의 징후 및 증상에 대한 적절하고 잘 통제된 연구에서 효능에 대한 실질적인 증거가 부족하다고 명시한 Complete Response Letter를 발행했습니다. 안전성 또는 제조 문제는 확인되지 않았습니다. Aldeyra는 잠재적 승인을 위한 다음 단계 논의를 위해 30일 이내에 Type A 미팅을 요청할 계획입니다.
핵심 사실
출처 발췌
EX-99.1 2 aldx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease Lexington, Mass., March 17, 2026 – Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The CRL stated that there is “a lack of substantial evidence consisting of adequate and well-cont