美国食品和药物管理局拒绝了Aldeyra的干眼药, 因为效果数据不一致, FDA rejects Aldeyra’s dry eye drug due to inconsistent efficacy data, causing stock to plummet.

由于FDA拒绝了Aldeyra Therapeutics的应用程序,该公司股票下跌68.6% ,这是对干眼病治疗的滴剂.自2023年以来,这已经是连续第三次获得完整响应信. Aldeyra Therapeutics’ stock dropped 68.6% after the FDA rejected its application for reproxalap, an eye drop for dry eye disease, marking the third consecutive Complete Response Letter since 2023. 该机构指出,由于试验结果不一致,疗效证据不足,但没有发现安全性或制造问题. The agency cited insufficient evidence of efficacy due to inconsistent trial results, though no safety or manufacturing issues were found. 美国食品和药物管理局没有要求进行额外的临床试验,但敦促Aldeyra调查试验变异性并确定潜在的患者亚组. The FDA did not require additional clinical trials but urged Aldeyra to investigate trial variability and identify potential patient subgroups. 该公司预计将在2028年之前拥有7000万美元的现金,计划与FDA要求进行A型会议,但不会进行进一步试验. The company, which has $70 million in cash expected to last through 2028, plans to request a Type A meeting with the FDA but will not conduct further trials. 这一决定影响了AbbVie,该公司拥有共同商业化药物的独家选择权,并可能支付高达3亿美元的里程碑. The decision impacts AbbVie, which holds an exclusive option to co-commercialize the drug with potential milestone payments of up to $300 million.