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欧康维视生物-B(01477):治疗术后炎症适应症新药OT-502于中国的III期临床试验患者入组已完成

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欧康维视生物-B(01477)发布公告,一款治疗术后炎症适应症的新药OT-502(地塞米松植入物)已于2023年11月29日于中国完成合共300名患者的III期临床试验入组。

OT-502(地塞米松植入物)是地塞米松(一种皮质类固醇)的单剂量缓释药物,用于治疗白内障术后炎症。迄今为止,OT-502是首种也是唯一一种获美国食品药品监督管理局批准用于术后炎症的单剂量缓释型后房内类固醇。集团正在开发 OT-502,作为中国白内障手术相关术后炎症的潜在同类首创疗法。OT-502的III 期临床试验为随机、双盲、安慰剂对照、平行组、多中心临床及药代动力学,以评估9%地塞米松植入物治疗白内障术后炎症的有效性及安全性。

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