Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the completion of patient enrollment in two Phase III trials for NVK-002, its core product for controlling myopia progression in children and adolescents. The studies, known as China CHAMP and Small CHAMP, mark a key milestone in the drug’s development pipeline.
Study Details
The China CHAMP study involves 19 clinical centers and 777 patients, while the Small CHAMP study includes 18 centers and 526 patients. Both trials evaluate NVK-002’s efficacy and safety in slowing myopia deepening in children aged 3 to 17.
Drug Profile
NVK-002 is a preservative-free eye drop administered nightly to halt myopia progression. The product was licensed from Nevakar in October 2020 for development and commercialization in Greater China, South Korea, and Southeast Asia.
Global Development
A separate three-year Phase III study led by Nevakar in Europe and the U.S. is set to conclude this year, with a New Drug Application (NDA) expected to be filed with the U.S. FDA in 2024.-Fineline Info & Tech
