歐康維視生物-B(01477.HK)治療兒童近視自研新藥獲內地批準開展III期臨牀試驗
歐康維視生物-B(01477.HK)公佈,治療兒童近視發展的自研新藥OT-101(0.01%硫酸阿託品滴眼液),獲中國國家藥品監督管理局藥品審評中心(CDE)批準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。
集團指,OT-101的III期臨牀試驗已成爲低濃度阿託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。於今年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託品眼用製劑。
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