China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced the completion of the last patient visit in the one-year Phase III bridging study, Mini-CHAMP, for its NVK002—an atropine external use eye solution for myopia progression.
Parallel Phase III Clinical Trials for NVK002
In addition to the Mini-CHAMP study, Zhaoke is conducting a parallel two-year Phase III clinical trial, China CHAMP, both designed 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. The China CHAMP trial includes 18 centers and has enrolled 777 patients, while the Mini-CHAMP trial involves 16 centers and has enrolled 526 patients.
NVK002: A Novel Preservative-Free Ophthalmic Solution
NVK002 is an investigational novel topical ophthalmic solution aimed at controlling myopia progression in children and adolescents. It is preservative-free and has an expected shelf life of over 24 months, making it a promising candidate for long-term use in managing myopia.
Licensing Deal and Global Reach
Zhaoke entered into a licensing agreement with US firm Nevakar Inc. in October 2020, securing exclusive development, manufacturing, and commercialization rights to NVK-002 in Greater China, South Korea, and Southeast Asia. Nevakar’s subsidiary Vyluma announced in June 2023 that a market filing for r NVK002 (low dose atropine 0.01%) as a potential treatment for myopia in children has been accepted for review by the US Food and Drug Administration (FDA).-Fineline Info & Tech
