Vyluma’s NVK002 Gains NMPA Acceptance in China

Vyluma has announced that the National Medical Products Administration (NMPA) of China has accepted the drug application for NVK002 (low-dose atropine 0.01%), submitted by Zhaoke Ophthalmology Limited. This milestone marks a crucial step toward the approval of NVK002 as a treatment for myopia progression in children.

Global Collaboration to Address Pediatric Myopia

NVK002 was developed by Vyluma and licensed to Zhaoke in 2020. Under the terms of their agreement, Zhaoke is responsible for:

• Developing and securing regulatory approval for NVK002 in Greater China, South Korea, and Southeast Asia

• Manufacturing, launching, distributing, and commercializing NVK002 in these regions

Significance of NMPA Acceptance

George Zorich, Chairman and CEO of Nevakar and Acting President of Vyluma, emphasized the importance of this regulatory milestone:

“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.”

Clinical Trials Supporting the Drug Application

The NMPA submission is supported by Mini-CHAMP, a Phase III clinical trial conducted by Zhaoke in China across 16 centers, enrolling 526 patients. Key findings include:

• The study met its primary efficacy endpoint, showing statistically and clinically significant improvements compared to placebo

• Strong safety and efficacy profile with high patient tolerance

Additionally, a second Phase III trial, China CHAMP, completed its last patient visit in August 2024. The topline results demonstrated significant efficacy and a favorable safety profile for NVK002.

Regulatory Progress and Future Outlook

NVK002 received FDA approval in 2023, reinforcing its potential as a safe and effective treatment for myopia progression. With China’s high pediatric myopia rates, the acceptance of NVK002’s drug application by the NMPA marks a critical step toward increasing treatment access for children in the region.

As Vyluma and Zhaoke continue advancing regulatory approvals, NVK002 remains positioned as a promising global solution for managing pediatric myopia and preserving long-term eye health.