兆科眼科-B(06622):澳洲THERAPEUTIC GOODS ADMINISTRATION(治疗用品管理局)受理评核硫酸阿托品滴眼液的注册申请

智通财经
Jan 13

智通财经APP讯,兆科眼科-B(06622)发布公告,于2026年1月5日,澳洲Therapeutic Goods Administration(治疗用品管理局)已受理评核本公司就其用于治疗儿童近视加深的硫酸阿托品滴眼液(0.01%剂量,产品代码:NVK002)提出的注册申请。

治疗用品局已正式知会本公司的申请已通过初步评审,将会进行评核。是项申请乃以本公司进行的第III期临床试验所获得的支持性结果为基础。

硫酸阿托品滴眼液(NVK002)乃一种用于控制儿童及青少年近视加深的试验性新型外用眼部溶液。硫酸阿托品滴眼液(NVK002)乃一项专利配方,成功解决低浓度阿托品的不稳性,此技术在全球均受到知识产权保护。硫酸阿托品滴眼液(NVK002)不含防腐剂,预计保存期逾24个月。

按照灼识咨询提供的资料,NVK002目前为全球用于治疗近视加深的最先进阿托品候选药物之一,目标患者组别最为广泛,涵盖3至17岁的儿童及青少年。

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