China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III mini CHAMP study for NVK002, an atropine external use eye solution developed to address myopia progression.
Study Design and Participants
The Phase III mini CHAMP study was a randomized, double-blind, placebo-controlled, multi-center trial that enrolled 526 children and adolescents across 16 centers in China. The study aimed to assess the efficacy and safety of NVK002 in alleviating the deepening of myopia among this demographic.
Achievement of Efficacy Endpoints
The mini CHAMP study successfully achieved its main efficacy endpoint, demonstrating that both 0.01% and 0.02% NVK002 showed statistically and clinically significant differences in slowing down the progression of myopia compared to the placebo. Both doses exhibited good tolerance and safety profiles, indicating their potential as effective treatments for myopia in children and adolescents.
Next Steps and Regulatory Filing
Zhaoke Ophthalmology plans to engage in discussions with regulatory authorities to advance the New Drug Application (NDA) filing for NVK002 in China. The filing will combine the results of the mini CHAMP study with those from the global Phase III CHAMP study, providing a comprehensive dataset to support the drug’s approval.
NVK002’s Unique Features
NVK002 is an investigational novel topical ophthalmic solution designed to control myopia progression in children and adolescents. It is preservative-free and has an expected shelf life of over 24 months, making it a convenient and potentially long-lasting treatment option for controlling myopia.-Fineline Info & Tech
