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歐康維視生物-B(01477.HK):OT-502於中國的III期臨牀試驗達到主要終點
格隆匯 04-15 12:11

格隆匯4月15日丨歐康維視生物-B(01477.HK)宣佈,一款治療術後炎症適應症的新藥OT-502(DEXYCU®,地塞米松植入劑)已成功達到其III期臨牀試驗的預期主要療效終點,即第8天時,地塞米松植入劑的治療組中眼前房細胞清除(ACC 0級)的受試者比例顯著高於安慰劑組,證明本品在控制白內障術炎症方面安全有效。公司預期將於近期向中國國家藥品監督管理局藥品審評中心遞交OT-502的新藥申請。

OT-502(地塞米松植入劑)是地塞米松(一種皮質類固醇)的單劑量緩釋藥物,用治療白內障術炎症。迄今為止,OT-502是首種也是唯一一種獲美國食品藥品監督管理局批准用炎症的單劑量緩釋型房內類固醇。集團正在開發OT-502,作為中國白內障手術相關術炎症的潛在同類首創療法。OT-502的III期臨牀試驗為隨機、雙盲、安慰劑對照、平行組、多中心臨牀及藥代動力學研究,以評估9%地塞米松植入劑治療白內障術炎症的有效性及安全性,已2023年11月中國完成患者入組。

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