Zhaoke Ophthalmology Announces First Patient Completes 3-Year Enrollment in Phase 3 Myopia Trial

Zhaoke Ophthalmology Pharmaceutical has announced that the first patient has completed 3-year enrollment in the phase 3 CHAMP (Childhood Atropine for Myopia Progression) study carried out by its partner, 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 3 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 3-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.

“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,” Navneet Puri, PhD, Founder, Chairman and Chief Executive Officer of Nevakar, said in a company news release.

“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, PhD, 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.