歐康維視生物-B(01477.HK)：OT-1001的III期臨牀試驗已達到主要臨牀終點
格隆匯3月2日丨歐康維視生物-B(01477.HK)發佈公吿，具有抗敏特性的強效及高選擇性組胺H-1受體拮抗劑OT-1001 (ZERVIATE)的III期臨牀試驗已達到主要臨牀終點並取得顯著效果。
根據披露，OT-1001 (ZERVIATE)由Nicox Ophthalmics, Inc.研發。OT-1001是抗組胺藥鹽酸西替利嗪(ZYRTEC®的活性成分)的首款且唯一的滴眼液配方，目前已於美國上市，用於治療過敏性結膜炎相關的眼癢。研究表明，OT-1001是一種安全有效的抗組胺治療劑。OT-1001起效迅速，滴眼後作用持續時間長達至少8 小時。OT-1001覆蓋的患者範圍廣泛。除成人外，OT-1001治療2歲及以上幼兒的安全性及有效性已確立，因此其滿足目前過敏性結膜炎幼兒患者治療的臨牀需求。集團於2019年3月獲Nicox獨家許可，以在大中華地區開發、製造、委託製造、進口、出口、使用、分銷、營銷、推廣、要約出售及銷售(或另行進行商業化)OT-1001 (ZERVIATE)，並於2020年3月將獨家權利擴大至東南亞11個國家。 OT-1001在中國的III期臨牀試驗已於2020年12月獲首位患者成功入組及用藥。
OT-1001的III期臨牀試驗設計為隨機、觀察者盲態、陽性對照、多中心平行組臨牀試驗，旨在通過比較0.05%濃度的富馬酸依美斯汀滴眼液，評核0.24%濃度的鹽酸西替利嗪滴眼液對患有過敏性結膜炎的中國患者的安全性及療效。共296名患者於中國的多個臨牀中心隨機分配。試驗表明OT-1001在第14天觀察期前24小時內瘙癢評分較基線的變化這一主要療效終點方面不遜於富馬酸依美斯汀。OT1001的安全性及耐受性良好，發生不良反應的患者比例與富馬酸依美斯汀相比並無差異。該臨牀試驗的成功完成是實現OT-1001商業化的重要一步。
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