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欧康维视生物-B(01477.HK):OT-1001(ZERVIATE)于中国III期临床试验获首名患者入组
格隆汇 12-29 22:29

格隆汇 12 月 29日丨欧康维视生物-B(01477.HK)公告,集团主要产品中具有抗敏特性的强效及高选择性组胺H-1受体拮抗剂OT-1001(ZERVIATE)在中国的III期临床试验已于2020年12月29日获首位患者成功入组及用药。

OT-1001(ZERVIATE)由NicoxOphthalmics,Inc.(连同其附属公司及联属人士,统称为"Nicox")研发,是首款且唯一经美国食品药品监督管理局("FDA")批准上市的抗组胺药盐酸西替利嗪眼用制剂,用于治疗过敏性结膜炎相关的眼痒。研究表明相比于现有的抗组胺治疗剂,OT-1001展现了更好的有效性及安全性。OT1001起效迅速,滴眼后作用持续时间长达至少8小时。

OT-1001患者复盖范围广,其是唯一一种除成人外还获得FDA批准用于治疗2岁及以上幼儿的眼科抗组胺药物,可满足目前过敏性结膜炎幼儿患者治疗的临床需求。

集团于2019年3月获Nicox独家许可,以在大中华地区开发、制造、委托制造、进口、出口、使用、分销、营销、推广、要约出售及销售(或另行进行商业化)OT-1001(ZERVIATE),并于2020年3月将独家权利扩大至东南亚11个国家。

OT-1001的III期临床试验设计为随机、观察者盲态、阳性对照、多中心平行组临床试验,评核0.24%浓度的盐酸西替利嗪滴眼液对患有过敏性结膜的中国患者的安全性及疗效,预期约有296名患者在约15间临床中心入组。

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