兆科眼科-B(06622.HK):FDA批準環孢素眼用凝膠的新藥試驗申請
格隆匯6月4日丨兆科眼科-B(06622.HK)公告,美國食品藥品監督管理局("FDA")已批準公司就環孢素眼用凝膠(公司核心產品之一,前稱環孢素A眼凝膠)用於治療中重度乾眼症作出的新藥臨牀試驗申請("新藥試驗申請")。該項即將進行的研究將爲一項第三期、多中心、隨機、雙盲、活性對照研究。
基於與FDA進行的全面科學溝通及討論,公司已與FDA達成一致意見,將已完成的關鍵第III期臨牀試驗(COSMO研究)以及正在中國進行的第III期臨牀試驗的數據納入其美國開發計劃。
環孢素眼用凝膠是公司於中國開發以供治療中重度乾眼症的創新環孢素凝膠。有別於Restasis®乳液配方,環孢素眼用凝膠是專利水凝膠,其專利權已於中國以至國際範圍獲批。此一創新配方提升環孢素於眼表的藥物代謝動力學效能及曝露量,給予環孢素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%環孢素眼用凝膠(每日晚間一次)的療效及安全特性至少與Restasis®(0.05%環孢素,每日兩次)者類近,有效消除日間給藥的需要以及相關的不適和不便。
此外,先前由公司進行的第III期研究(COSMO)結果顯示,環孢素眼用凝膠最早可於兩星期起效。通過每日一次用藥及迅速起效,公司的環孢素眼用凝膠有望顯著改善患者的用藥依從性和生活質量。
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