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歐康維視生物-B(01477.HK):OT-101在英國提交臨牀試驗許可以啟動III期臨牀試驗獲受理
格隆匯 05-20 19:09

格隆匯5月20日丨歐康維視生物-B(01477.HK)公吿,一項臨牀試驗許可最近已獲英國藥品及保健品管理局(Medicines and Healthcare products Regulatory Agency)受理,以在英國啟動本集團的自主研發產品OT-101的國際多中心III期臨牀試驗("III期MRCT")。III期MRCT一經批准,OT-101預計將成為低濃度阿托品及其類似物全球首個包含中國人羣在內的III期MRCT。

OT-101是集團開發的一種低濃度阿托品0.01%滴眼液,用於延緩或減慢兒童和青少年近視的進度。低濃度阿托品溶液並不穩定,故一直存在商業化的技術障礙。集團開發了一種存儲及給藥系統,以解決低濃度阿托品溶液的不穩定性,並亦已對系統可靠性、密封完整性及無菌條件進行了多輪測試。

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