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歐康維視生物-B(01477.HK)第六款產品進入III期臨牀試驗階段-OT-502(DEXYCU®)獲藥品審評中心批准於中國開展III期臨牀試驗
格隆匯 09-14 18:39

格隆匯9月14日丨歐康維視生物-B(01477.HK)宣佈,集團的主要候選藥物之一OT-502(DEXYCU®)獲中華人民共和國國家醫藥產品管理局藥品審評中心("藥品審評中心")批准於中國開展III期臨牀試驗。

OT-502(DEXYCU®)於2018年2月9日在美國獲得食品藥品監督管理局("FDA")批准上市,為第一款及唯一一款FDA批准的治療術後炎症適應症的眼內緩釋藥物。炎症是白內障手術後常見的症狀,倘不及時治療,可能會導致嚴重的併發症。迄今為止,臨牀上常規使用激素和抗生素滴眼液二至四周來治療術後炎症。然而,白內障手術患者多為老年人,用藥依從性較差。OT-502可利用藥物遞送平台Verisome®將地塞米松遞送至前房,直接抑制前房內炎症介質的合成和釋放。OT-502(DEXYCU®)有效抑制術後前房炎症反應,避免了局部激素滴眼液的頻繁使用,有效解決白內障患者術後用藥依從性不佳問題,為白內障術後炎症的管理提供更好的治療選擇。

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