億勝生物科技(01061.HK):用以治療溼性AMD中國患者的anti-VEGF眼用注射生物藥品(HLX04-O)的三期臨牀研究(AURA-1)結果已達到主要研究終點
格隆匯4月2日丨億勝生物科技(01061.HK)公告,用以治療溼性AMD中國患者的anti-VEGF眼用注射生物藥品(HLX04-O)的三期臨牀研究(AURA-1)結果已達到主要研究終點。
AURA-1爲一項多中心、隨機、雙盲、陽性對照的非劣效三期臨牀研究,旨在比較HLX04-O與雷珠單抗玻璃體腔注射(IVT)治療新診斷溼性AMD患者的有效性和安全性。入組的患者按照1:1的比例隨機接受HLX04-O(1.25mg)IVT或雷珠單抗(0.5mg)IVT給藥,每四周一次,在患者未發生死亡、撤回知情同意、失訪或申辦方終止研究的情況下,治療持續一年。本次研究的主要研究終點爲第48周最佳矯正視力(BCVA)較基線改善的平均字母數變化,次要研究終點爲其他有效性、安全性、耐受性及藥代動力學指標。研究結果顯示,HLX04-O組第48周BCVA較基線改善的平均字母數變化結果非劣於雷珠單抗組,達到主要研究終點。此外,HLX04-O與雷珠單抗在溼性AMD患者中的整體、眼部及非眼部安全性特徵相似,安全性良好。
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