公司同时进行一项并行、为期两年的第III期临床试验，并于2024年8月完成最后一名患者的最后一次访视。该项试验涉及18间中心，入组777名患者。China CHAMP的顶线结果显示NVK002具有显著的安全性及疗效，足证该药物可作为儿童近视加深的潜在治疗方案。ZHAOKE OPHTH-B (06622) announced that the State Drug Administration of China has accepted the application for one of the company's core products, ...
According to the Zhithong Finance APP, ZHAOKE OPHTH-B (06622) announced that the State Drug Administration of China has accepted the simplified new drug application for one of the company's core products, NVK002 (low-dose atropine 0.01%), which is used to treat worsening myopia in children.
This simplified new drug application is based on its Phase III clinical trial results in China. In August 2023, the company completed the last visit of the last patient in a one-year Phase III clinical trial in China. The trial involved 16 centers and enrolled 526 patients. The small CHAMP successfully achieved the primary efficacy indicators, showing statistical and clinical significance compared to the placebo, as well as demonstrating strong safety, efficacy, and high patient tolerance.
The company is also conducting a parallel two-year Phase III clinical trial, which will complete the last visit of the last patient in August 2024. This trial involves 18 centers and enrolls 777 patients. The top-line results of China CHAMP indicate that NVK002 has significant safety and efficacy, providing evidence that this drug could be a potential treatment option for worsening myopia in children.
