Vyluma announces NMPA of China accepts drug application of NVK002 (low-dose atropine 0.01%) for myopia progression in children

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Key Takeaways

NVK002, a low-dose atropine, targets myopia progression in children and has been accepted by China's NMPA for drug application.
Zhaoke Ophthalmology is responsible for NVK002's development and commercialization in Greater China, South Korea, and Southeast Asia.
Phase III trials, Mini-CHAMP and China CHAMP, showed NVK002's significant efficacy, safety, and patient tolerance.
NVK002 received FDA approval in 2023, aiming to combat high pediatric myopia rates in China and improve children's vision and quality of life.

Zhaoke Ophthalmology Limited is responsible for developing and obtaining regulatory approval for NVK-002 in Greater China, South Korea, and the Southeast Asian territories.

(Image Credit: AdobeStock/millaf)

Vyluma announced the National Medical Products Administration (NMPA) of China has accepted the drug application from Zhaoke Ophthalmology Limited for its lead compound, NVK002 (low-dose atropine 0.01%) as a potential treatment for myopia progression in children.

NVK002 was developed by Vyluma and licensed to Zhaoke in 2020. Under the terms of the agreement, Zhaoke develops and obtains regulatory approval for NVK-002 in Greater China, South Korea and the Southeast Asian territories. In those areas Zhaoke will also manufacture, launch, distribute, and support the commercialization of the NVK002.^1,2

George Zorich, chairman and CEO of Nevakar, and acting president of Vyluma, commented on the acceptance in a press release from Vyluma.¹

“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 Zorich. “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 a total of 526 patients. According to the company, the trial successfully met its primary efficacy endpoint, achieving statistically and clinically meaningful differences versus placebo, and demonstrated strong safety and efficacy and high patient tolerance.¹

A second phase III clinical trial, China CHAMP, from Zhaoke completed the last patient last visit in August 2024. Topline results from the trial showed a “significant efficacy and favorable safety profile of NVK002.”

NVK002 was approved by the US Food and Drug Administration (FDA) in 2023.

References:

Vyluma announces acceptance of drug application for NVK002 by China’s National Medical Products Administration (NMPA). Press Release. Published January 29, 2025. Accessed January 29, 2025.https://vyluma.com/press_release/vyluma-announces-acceptance-of-drug-application-for-nvk002-by-chinas-national-medical-products-administration-nmpa/
Nevakar and zhaoke ophthalmology enter into licensing agreement for nvk002 (atropine for the treatment of the progression of myopia in children). Press release. Published October 20, 2020. Accessed January 29, 2025. https://vyluma.com/press_release/nevakar-and-zhaoke-ophthalmology-enter-into-licensing-agreement-for-nvk-002-atropine-for-the-treatment-of-the-progression-of-myopia-in-children/