Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, is pleased to announce that the last patient last visit was completed for the one-year Phase III bridging clinical trial (“Mini-CHAMP”) of one of the Company’s core products, NVK002 for the treatment of myopia, on 3 August 2023.
Zhaoke Ophthalmology ran Mini-CHAMP concurrently with a parallel two-year Phase III clinical trial (“China CHAMP”). The main objective of both China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 (low dose atropine 0.01% and 0.02%) in the treatment of myopia progression in children and adolescents in Chinese population. The China CHAMP trial involves 18 centers and enrolled 777 patients; the Mini-CHAMP trial involved 16 centers and enrolled 526 patients. The completion of Mini-CHAMP’s last patient last visit is an important step forward to the Company’s submission of New Drug Application (“NDA”) in China.
On 7 June 2023, the Company reported an announcement from its partner, Vyluma Inc. (“Vyluma”), concerning the U.S. Food and Drug Administration’s acceptance for review of the NDA for NVK002 (low dose atropine 0.01%) as a potential treatment for myopia in children. NVK002 is currently positioned as the world’s first clinically-proven pharmaceutical product approved for treating the progression of myopia.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are excited to see the completion of treatment for all patients in our Mini-CHAMP trial. This marks another important milestone for Zhaoke as it is an important step forward to our submission of NDA in China. There are currently over 163 million children and adolescents suffering from myopia in China. We hope that we can support these kids and their families to control their myopia progression by bringing NVK002 to the market as quickly as possible.”
About NVK002
NVK002 is an investigational novel topical ophthalmic solution to control myopia progression in children and adolescents. NVK002 has a proprietary formulation that successfully addresses the instability of low-concentration atropine; this technology has intellectual property protection globally. NVK002 is preservative-free with an expected shelf life of over 24 months. According to information from China Insights Consultancy (“CIC”), NVK002 is currently one of the most advanced atropine drug candidates globally for treating myopia progression, and targets the broadest patient group, covering children and adolescents from three to 17 years old.
The clinical development of NVK002 involves two different concentrations of atropine to allow flexibility in achieving maximal efficacy and minimal adverse effects when tailoring to the needs of individual patients.
About the License Agreement with Vyluma Inc.
In October 2020, the Company entered into a license agreement, namely the NVK002 License Agreement, with Nevakar Inc., which later assigned the agreement to its wholly-owned subsidiary, Vyluma Inc. for an exclusive license to develop, manufacture, register, import and commercialize NVK002 in Greater China, South Korea and certain countries in Southeast Asia (including Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand and Vietnam). For details of the license agreement in relation to NVK002, please refer to “Business – Collaboration and License Agreements – License of NVK002” of the prospectus of the Company dated April 16, 2021.
