兆科眼科-B(06622.HK)治療兒童近視加深藥物III期臨床試驗達到主要療效終點
兆科眼科-B(06622.HK)公布,其核心產品之一NVK002為期一年的第III期臨床試驗(小型CHAMP)的頂線結果。研究分析顯示,NVK002作為治療兒童近視加深的潛在療法具有強健的安全性及療效,且與公司美國夥伴Vyluma所進行的第III期CHAMP臨床研究首年的趨勢吻合。
小型CHAMP成功達到主要療效終點。與使用安慰劑相比,0.01%及0.02%劑量的NVK002對減緩研究對象近視加深均表現出統計學及臨床意義方面的差異。NVK002在兩個劑量上均具有良好的耐受性及安全性,分別從較低的治療中斷率及眼部嚴重不良事件兩項可見一斑。
公司計劃與監管機構溝通,藉結合小型CHAMP的結果與Vyluma的第III期CHAMP研究數據,推進中國NVK002新藥申請的進度。
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