恆瑞醫藥(600276.SH)研發的SHR8058滴眼液治療瞼板腺功能障礙相關乾眼病Ⅲ期臨牀試驗(SHR8058-301)主要研究終點結果達到方案預設優效標準
格隆匯11月30日丨恆瑞醫藥(600276.SH)公佈，近日，公司研發的SHR8058滴眼液治療瞼板腺功能障礙相關乾眼病的多中心、隨機、雙盲、鹽溶液平行對照Ⅲ期臨牀試驗(SHR8058-301)主要研究終點結果達到方案預設的優效標準。
研究結果表明，與安慰劑對比，SHR8058滴眼液可以治療瞼板腺功能障礙相關乾眼病，顯著改善患者的乾眼病症狀和體徵。同時，SHR8058滴眼液安全可靠，局部耐受性好，滴藥後局部感覺異常發生率與安慰劑相當。公司將於近期向國家藥品監督管理局藥品審評中心遞交上市前的溝通交流申請。
SHR8058-301研究是一項評價SHR8058滴眼液治療瞼板腺功能障礙相關乾眼病的有效性和安全性的多中心、隨機、雙盲、鹽溶液平行對照Ⅲ期臨牀試驗。由首都醫科大學附屬北京同仁醫院接英教授擔任主要研究者，全國17家中心共同參與。主要研究終點是：1.治療結束時(第57天)全角膜熒光素染色評分(tCFS)較基線的變化；2.治療結束時(第57天)眼乾的嚴重程度評分(VAS)較基線的變化。次要研究終點包括不同訪視點全角膜染色評分、各個分區角膜染色評分、乾眼視覺模擬量表(VAS)和OSDI問卷的各項評分及其較基線的變化和安全性等。
SHR8058滴眼液是一種無色、透明的滴眼液，由100%全氟己基辛烷組成，能迅速擴散至整個眼表，並與淚膜的親脂部分相互作用，穩定淚膜、防止淚液過度蒸發。此外，SHR8058滴眼液可穿透瞼板腺，與腺體相互作用並溶解腺體中的粘性分泌物，從而達到治療瞼板腺功能障礙相關蒸發過強型乾眼病的作用。
經查詢，除德國Novaliq公司的NovaTears在歐盟和澳大利亞已作為醫療器械上市外，目前無同機製藥品上市,暫未查詢到NovaTears2020年全球銷售數據。
截至目前，SHR8058相關項目累計已投入研發費用約為6890萬元。
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