歐康維視生物-B(01477.HK)於海南啟動OT-401真實世界研究
格隆匯 11 月 30日丨歐康維視生物-B(01477.HK)公告,近期集團已於中國海南省博鰲超級醫院啟動其核心產品OT-401(YUTIQ)的真實世界研究,並同步於全國多個眼科臨牀中心招募患者。
同時,OT-401的III期臨牀研究亦於全國多個眼科臨牀中心展開,該臨牀研究評估用於眼後段慢性非感染性葡萄膜炎患者氟輕鬆玻璃體植入劑的安全性及療效。OT-401的真實世界研究數據預期將為OT-401的III期臨牀試驗數據提供支持及補充。
相較於傳統的臨牀試驗,真實世界研究是一種更具成效益且耗時較短的輔助研究,其目標是通過分析在真實世界環境蒐集到的患者相關數據,就藥品使用及潛在利益或風險形成臨牀證據。啟動OT-401真實世界研究預期將加速於中國的新藥申請註冊。
公司的核心產品OT-401(YUTIQ)是一種同類首創、創新的可注射、緩釋微型植入劑,用於治療累及眼後段的慢性非感染性葡萄膜炎。OT-401是一種無菌、非生物降解的玻璃體內植入劑,該植入劑將在門診單次植入後36個月內,按經控制速度持續釋放共計0.18毫克活性成分氟輕鬆(一種皮質類固醇)。
迄今為止,YUTIQ是首款且唯一經美國食品藥品監督管理局批准可釋放氟輕鬆長達36個月的葡萄膜炎療法。
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