According to the Zhitong Finance App, Zhaoke Ophthalmology-B (06622) released the top line results of the one-year phase III clinical trial (small CHAMP) of NVK002 (one of the company's core products). After a year of treatment, this multi-center study analysis showed that NVK002 has strong safety and efficacy as a potential treatment for the deepening of myopia in children, and is in line with the trend of the first year of the phase III CHAMP clinical study conducted by the company's US partner Vyluma, Inc. (Vyluma).
Phase III small-scale CHAMP is a randomized, double-blind, placebo-controlled, multicenter clinical study. The main goal is to evaluate the efficacy and safety of NVK002 in reducing the progression of myopia in Chinese children and adolescents. The trial involved 16 centers and enrolled 526 children and adolescents. Professor Qu Xiaomei of the Eye, Ear, Nose and Throat Hospital affiliated to Fudan University and Professor Yang Xiao of the Zhongshan Ophthalmology Center of Sun Yat-sen University acted as co-lead researchers.
The study was divided into two stages: a one-year treatment period to evaluate the safety and efficacy of NVK002. After that, enrolled patients were randomly re-treated for a period of one year for single blindness to summarize the characteristics of stopping treatment.
Small CHAMP successfully reached the main therapeutic end point. Compared with placebo, 0.01% and 0.02% doses of NVK002 showed differences in statistical and clinical significance in reducing the deepening of myopia in study subjects.
NVK002 has good tolerability and safety at both doses, as can be seen from the lower treatment interruption rate and serious ocular adverse events, respectively.
The company plans to communicate with regulators to advance the progress of China's NVK002 new drug application by combining the results of the small CHAMP with Vyluma's Phase III CHAMP study data.
The company is conducting a parallel, two-year phase III clinical trial (CHAMP China). The CHAMP trial in China involved 18 centers and enrolled 777 patients. Patient enrollment was completed on July 21, 2022.
On October 11, 2023, Vyluma announced the positive top-line results of the second phase of its NVK002 phase III CHAMP clinical study. After four years of treatment and follow-up, an analysis of the results of this multi-center, international study showed that NVK002, as a potential treatment for myopia in children, had continued and strong safety and continued efficacy, and there was no rebound after drug elution in the study.
NVK002 is an experimental novel topical eye solution for controlling the deepening of myopia in children and adolescents. NVK002 is a patented formula that successfully addresses the instability of low concentrations of atropine. This technology is protected by intellectual property rights around the world. NVK002 contains no preservatives and is expected to last at least 24 months. According to data provided by Knowledge Industry Consulting Co., Ltd., NVK002 is currently one of the most advanced atropine drug candidates in the world for the treatment of deepening myopia. It targets the broadest range of patients, covering children and adolescents aged 3 to 17. The clinical development of NVK002 involves two types of atropine in different concentrations to meet the needs of individual patients and flexibly achieve optimal efficacy and minimal side effects.