Evaluating Low-Dose Atropine Ophthalmic Solution for the Treatment of Myopia in Children
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Ltd. (“Zhaoke Hong Kong”) is pleased to announce today that the first patient has completed three year enrollment in the Phase III CHAMP (Childhood Atropine for Myopia Progression) study carried out by its partner, Nevakar Inc. (“Nevakar”). The CHAMP Study is an FDA drug trial that evaluates the ability of its lead compound, NVK-002, to slow the progression of myopia in children. NVK-002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages three to seventeen.
NVK-002 is a novel and first-to-market pharmacologic treatment for slowing the progression of myopia in children. It is currently under clinical evaluation in the CHAMP study and has entered Phase 3 clinical trial in the US and Europe. The CHAMP trial follows ground-breaking studies conducted in Asia that concluded that low doses of atropine could be used to slow the progression of myopia in children. CHAMP is a 576 subject, randomized, placebo-controlled, double-masked study evaluating the effects of NVK-002 on myopia progression in children. The study duration is three years, after which enrolled patients are re-randomized for a fourth year of follow-up. With this milestone, the trial remains on-track for a three-year data readout in 2022.
On October 19, 2020, Zhaoke Hong Kong and Nevakar entered into an exclusive licensing agreement for the development and commercialization of Nevakar’s NVK-002 in Greater China (The People’s Republic of China (“PRC”), Hong Kong SAR, Macau SAR and Taiwan), South Korea and the Southeast Asian territories.*
Under the terms of the agreement, Zhaoke Hong Kong will develop and obtain regulatory approval for NVK-002 in the contractual territory as well as manufacture, launch, distribute, and support the commercialization of the product.
Zhaoke Hong Kong is a wholly owned subsidiary of Zhaoke Ophthalmology Limited, which has a strong foundation in ophthalmology and is an emerging leader in the integrated eye care field in the PRC and Asia. Currently, there are over 100 million children with myopia in China.
“Despite the many challenges posed by the COVID-19 pandemic, Nevakar has achieved this important milestone in the development of our lead compound, NVK-002, which, if approved, would represent an innovative, first-to-market pharmacologic treatment for myopia in children,” stated Navneet Puri, PhD, Founder, Chairman and Chief Executive Officer of Nevakar.
“Nevakar’s NVK-002 is the most advanced innovative atropine product in development for the treatment of myopia. In-licensing of NVK-002 not only puts Zhaoke Ophthalmology in the leading position in the fight against myopia in China, Southeast Asia and South Korea but also strengthens its already comprehensive pipeline in ophthalmology,” said Dr. Benjamin Li, Ph.D., Chairman and Chief Executive Officer of Zhaoke Ophthalmology Limited.
*Southeast Asian territories include: Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.
About Nevakar Inc.
Nevakar Inc. is growing as 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 patient care and quality of life. Nevakar utilizes the 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 (Hong Kong) Ophthalmology Pharmaceutical Limited
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Ltd. is a wholly owned subsidiary of Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”), which specializes in the development, manufacturing and marketing of ophthalmic drugs. It has built a state-of-the-art development and production facility in Nansha, Guangzhou through its 100% subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited. The facility supports the in-house development and future commercialization of more than twenty proprietary products and difficult to manufacture generics (ranging from pre-clinical to registration stage) for the Chinese and ASEAN markets. It is currently the only modern facility in China that is recognized as being designed and built for ophthalmic drugs according to all applicable standards, namely China National Medical Products Administration, Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Medicines Evaluation Agency, Japan Pharmaceutical and Food Safety Bureau and U.S. Food and Drug Administration (FDA). Zhaoke Ophthalmology portfolio is diversified in having both small molecules and biologics, and having both novel and generic medicines, covering different ophthalmic indications from dry eye, glaucoma, wAMD, diabetic retinopathy to corneal and inflammatory diseases.