Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression.
The Phase III study, a randomized, double-blinded, placebo-parallel controlled, multi-center trial, was conducted to evaluate the efficacy and safety of NVK002 (low dose atropine 0.01% and 0.02%) in treating myopia progression in children and adolescents within the Chinese population. Encompassing 18 clinical centers, the study enrolled 777 patients. Over the course of two years of treatment, the NVK002 group, administered both 0.01% and 0.02% doses, demonstrated statistically significant improvements in the primary efficacy indicators compared to the placebo group, with superior results in the NVK002 group and a dose-dependent effect observed. Both doses exhibited favorable safety profiles and good patient compliance.
NVK002 is an investigational novel topical ophthalmic solution for controlling myopia progression in children and adolescents. It is preservative-free, with an anticipated shelf life of over 24 months. The solution targets the largest patient group, including children and adolescents aged between 3 to 17 years.- Flcube.com
