Vyluma, Inc. | MedPath

China's NMPA Accepts Vyluma's NVK002 Drug Application for Pediatric Myopia

4 months ago

• China's National Medical Products Administration (NMPA) has accepted the drug application for Vyluma's NVK002 to treat myopia progression in children. • NVK002 (low-dose atropine 0.01%) is a preservative-free eye drop administered nightly and developed by Vyluma, licensed to Zhaoke Ophthalmology. • The application is supported by Phase III trials, Mini-CHAMP and China CHAMP, demonstrating significant efficacy, safety, and patient tolerance versus placebo. • NVK002 is now under regulatory review in the United States, the European Union, and China, marking a significant step in its global availability.