拨康视云-B(02592)：美国药管局已完成对CBT-199的安全性审查

智通财经

Apr 30

智通财经APP讯，拨康视云-B(02592)发布公告，本公司于美利坚合众国(美国)特拉华州注册成立的全资附属公司 ADS Therapeutics LLC (ADS USA)，已完成有关于2025年12月12日向美国食品及药物管理局(美国药管局)提交的CBT-199(一种由本集团开发的潜在同类最佳眼科候选药物)新药临床试验申请(新药临床试验申请)的审查期。美国药管局已完成对新药临床试验申请的安全性审查，而美国药管局的结论为本公司可推进拟议的临床研究。

CBT-199是一种新型局部眼用乳液，适用于治疗老花眼，而老花眼为常见的年龄相关性病症，患者眼内晶状体逐渐增厚且失去弹性，导致聚焦近物能力持续衰退。CBT-199采用本集团专有的非水溶性平台制剂，含副交感神经性缩瞳剂，透过诱导瞳孔收缩形成针孔效应，增加焦距深度从而改善近距离视力。此无水配方旨在防止活性成分随时间分解以提升药物稳定性，并采用对消费者友善的自保存多剂量瓶装设计，具备长效保质期，提供舒适、舒缓的用药体验。

本公司认为，由于美国药管局已完成对CBT-199的安全性审查，标志着CBT-199临床开发的关键里程碑。本集团将持续密切关注审评进度，并适时另行刊发公告，以知会本公司股东及潜在投资者有关本集团业务的最新发展。

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