Vyluma, a biopharmaceutical company advancing novel treatments for refractive errors, announced today that the National Medical Products Administration (NMPA) of China has accepted the drug application from Zhaoke Ophthalmology Limited (“Zhaoke”) for its lead compound, NVK002 (low-dose atropine 0.01%), as a potential treatment for myopia progression in children. NVK002, developed by Vyluma and licensed to Zhaoke, is a proprietary, investigational, preservative-free eye drop administered nightly, targeting pediatric patients with myopia.
Acceptance of the drug application by the NMPA marks an essential step in introducing NVK002 as a potential therapeutic option for managing myopia in children across China.
“NMPA acceptance of the drug application for NVK002 is a significant milestone for Vyluma and underscores our commitment to addressing the global pediatric myopia epidemic,” said George Zorich, Chairman and CEO of Nevakar, Inc., and acting President of Vyluma, Inc. “China is home to one of the highest rates of pediatric myopia in the world, making this approval process critical for ensuring access to an innovative treatment that could dramatically impact the vision and quality of life for millions of children later in life. This acceptance is a testament to our dedication to advancing effective, science-based solutions for pediatric eye health worldwide.”
The drug application is based on the first Phase III clinical trial (“Mini-CHAMP”) conducted by Zhaoke in China. The trial involved 16 centers and enrolled 526 patients. Mini-CHAMP successfully met its primary efficacy endpoint, achieving statistically and clinically meaningful differences versus placebo, and demonstrated strong safety and efficacy and high patient tolerance.
A second Phase III clinical trial (“China CHAMP”) from Zhaoke completed the last patient last visit in August 2024. The trial involves 18 centers and enrolled 777 patients. The top-line results of China-CHAMP showed significant efficacy and favorable safety profile of NVK002, further supporting the drug as a potential treatment for myopia progression in children.
With its acceptance by the NMPA, NVK002 is now under regulatory review across three major global markets: the United States, the European Union, and China. This milestone reinforces Vyluma’s vision of bringing innovative pharmaceutical solutions to children worldwide and advancing the treatment of myopia progression globally.
