歐康維視生物-B(01477.HK):治療兒童近視發展自研新藥OT-101獲CDE批准開展III期臨牀試驗
格隆匯7月13日丨歐康維視生物-B(01477.HK)發佈公吿,治療兒童近視發展的自研新藥OT-101(0.01%硫酸阿托品滴眼液)獲中國國家藥品監督管理局藥品審評中心(CDE)批准開展一項治療兒童受試者近視進展的安全性和有效性的III期、隨機、雙盲、平行組、安慰劑對照、多中心臨牀試驗。
OT-101的III期臨牀試驗已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期國際多中心臨牀試驗。於2021年4月,OT-101的III期臨牀試驗在美國已完成首例受試者入組。OT-101在英國及歐盟遞交的III期臨牀試驗申請最近亦已獲受理。目前,全球主流醫藥市場範圍內尚未有商業化的低濃度阿托品眼用製劑。
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,OT-101使用了獨家設計的創新密閉式分體裝置,對裝置的可靠性、密封完整性及無菌條件均進行了諸多完善,使之最大程度地貼近低濃度阿托品目前院內製劑現配現用的用藥環境,解決了低濃度阿托品溶液在中性環境下的穩定性問題,適宜的pH值也改善了患者用藥的舒適度,提升了用藥依從性。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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