Zhaoke Ophthalmology receives NMPA acceptance for myopia drug

Zhaoke Ophthalmology Limited has announced that the National Medical Products Administration (NMPA) of China has accepted its New Drug Application (NDA) for NVK002 (Atropine Sulphate Eye Drops 0.02%), a core product aimed at treating myopia progression in children. The NDA is currently under review as a Class II innovative drug. This follows a previous announcement on January 2, 2025, regarding the acceptance of an Abbreviated New Drug Application (ANDA) for NVK002 (Atropine Sulphate Eye Drops 0.01%). NVK002 is presented as a novel topical ophthalmic solution designed to control myopia progression in children and adolescents, and it targets the large patient group of 3-17 year olds. The company believes that commercialization of NVK002 would establish a leading position in addressing the large unmet needs of the approxiamately 163 million children and adolescents suffering from Myopia in China.