智通财经APP讯,兆科眼科-B(06622)发布公告,美国食品药品监督管理局(FDA)已批准公司就环孢素眼用凝胶(公司核心产品之一,前称环孢素A眼凝胶)用于治疗中重度干眼症作出的新药临床试验申请。该项即将进行的研究将为一项第三期、多中心、随机、双盲、活性对照研究。
基于与FDA进行的全面科学沟通及讨论,公司已与FDA达成一致意见,将已完成的关键第III期临床试验(COSMO研究)以及正在中国进行的第III期临床试验的数据纳入其美国开发计划。
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