BRIDGEWATER, N.J., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“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.
About Vyluma, Inc.
Vyluma is a clinical-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children aged 3 years and older. Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain.
Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For additional information please visit www.vyluma.com.
About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the US 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.
About Zhaoke Ophthalmology Limited
Founded in 2017 in China, Zhaoke (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021.
Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering major eye diseases across both the front- and the back-of-the-eye. Currently, the company is focusing on major near-term development programs that are in the pre-registration stage, pivotal phase III clinical trial and other stages in clinical trial for the treatment of five respective major ophthalmic diseases, i.e. dry eye disease, myopia, wet AMD, presbyopia and cornea epithelial defects. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou, Guangdong Province in China.
Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology’s goal is to become a global leader in ophthalmology. For more information, please visit: www.zkoph.com.
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