兆科眼科-B(06622.HK)：環孢素A眼凝膠關鍵第III期臨牀試驗(COSMO)達到預設主要研究終點
格隆匯8月17日丨兆科眼科-B(06622.HK)宣佈，環孢素A眼凝膠(公司主要候選藥物之一，用於治療乾眼症)關鍵第III期臨牀試驗顯示該研究的下角膜螢光素染色法分數(ICSS)達到預設主要研究終點。
比較接受安慰劑治療的患者，接受環孢素A眼凝膠(0.05%,q.d.)的患者在病情改善上具有顯著統計學差異(P<0.0001)及臨牀意義。
詳細結果預期於詳細數據分析完成後在下一次醫療會議上公佈。
於中國進行的比對環孢素A眼凝膠與安慰劑對中至嚴重程度乾眼症對象的多中心、隨機、雙盲、安慰劑對照、效能及安全性研究(COSMO研究；clinicaltrials.gov登記編號：NCT04541888)旨在評估環孢素A眼凝膠對中重度乾眼症患者的療效及安全性，涉及41個臨牀試驗中心，自2020年12月起招募合共644名患者入組，招募工作於2021年4月中提早兩個月完成。公司的目標仍為於2021年底前向國家藥品監督管理局(藥監局)提交新藥申請。
環孢素A眼凝膠是公司於中國開發以供治療乾眼症的創新環孢素凝膠。有別於Restasis乳液配方，環孢素A眼凝膠是專利水凝膠，其專利權已於中國以至國際範圍獲批。此一創新藥方提升環孢素A於眼表的藥物代謝動力學效能及曝露量，給予環孢素A更多時間抑制乾眼症。事實上，先前的第II期研究結果顯示，0.05%環孢素A眼凝膠(q.d.)的效能及安全特性至少與Restasis(0.05%環孢素A,b.i.d.)者類近。通過消除所有日間給藥以及相關的不適和不便，公司的環孢素A眼凝膠每晚一次給藥，有望顯著改善患者的遵醫囑性和生活質量。
乾眼症是一種多因素造成並涉及炎症及多種症狀的複雜眼表疾病，併為中國乃至全球最常見的眼科疾病之一。根據灼識行業諮詢有限公司的資料，預計2030年中國乾眼症藥物的市場規模將自2019年的4.30億美元增長至67億美元，複合年增長率為28.4%。
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