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歐康維視生物-B(01477.HK):OT-101III期臨牀試驗首例美國受試者入組暨擬於中國開展OT-101的計劃真實世界研究
格隆匯 04-07 22:40

格隆匯 4 月 7日丨歐康維視生物-B(01477.HK)公吿,集團的主要自研候選藥物一OT-101(阿托品0.01%)於2021年4月7日已完成於美國治療小兒近視進展的安全性及有效性的III期隨機、雙盲、安慰劑對照組、平行組及多中心臨牀試驗首例受試者入組。

公司亦擬於中國海南省博鰲樂城醫療旅遊先行區開展OT-101的真實世界研究,以加速OT-101的商業化進程。

OT-101(阿托品0.01%)是一種低濃度(0.01%)阿托品滴眼液,用於延緩或減慢兒童和青少年近視的進度,亦是迄今為止唯一被證實在控制近視加深方面持續有效及安全的抗膽礆藥物。

然而,低濃度阿托品溶液的不穩定性長期以來一直是商業化的技術障礙。為解決該等障礙,集團已開發儲存及交付系統,並對系統的可靠性、密封完整性及無菌條件進行了多輪測試。集團相信,解決低濃度(0.01%)阿托品穩定性問題的技術突破將是其核心競爭力。

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