— Both Phase III clinical trials of NVK002 completed patient recruitment significantly ahead of schedule
— Gives Zhaoke Ophthalmology the opportunity to establish a leading position in meeting the huge unmet need in China, South Korea and parts of Southeast Asia for myopia progression control drugs
Zhaoke Ophthalmology Limited (Zhaoke Ophthalmology or the Company, HKG: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, is excited to announce that the patient enrollments for the two-year Phase III clinical trial (China CHAMP) and the concurrent one-year Phase III bridging clinical trial (Mini-CHAMP) of one of the Company’s core products, NVK002, were completed on 21 July 2022 and 28 July 2022 respectively significantly ahead of schedule.
The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents.
— China CHAMP
Led by Principal Investigator Professor Wang Ning Li from Beijing Tongren Hospital, the China CHAMP trial involves 19 centers. Enrolment of 777 patients has been completed in less than four months, two months ahead of schedule.
Co-led by Principal Investigators Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from Zhongshan Ophthalmic Center, Sun Yat-Sen University, the Mini-CHAMP trial involves 18 centers and the enrolment of 526 patients has been completed in less than three months, three months ahead of schedule.
These early completions of patient recruitment across both trials give the company a strong headstart in moving towards its goal to lead the market in launching a myopia progression treatment drug.
In the United States and Europe, the Company’s partner, Vyluma Inc., has been conducting a parallel Phase III clinical trial CHAMP, with three years of NVK002 treatment, and the trial is expected to be completed in 2022. Following this, a New Drug Application (NDA) submission to the US Food and Drug Administration (the FDA) is expected in 2023. NVK002 is currently thought to be the most likely first clinically proven and approved pharmaceutical product for treating the progression of myopia in the world.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, “The early completion of the patient recruitment of NVK002’s Phase III clinical trials marks another huge and exciting milestone for Zhaoke Ophthalmology. Both China CHAMP and Mini-CHAMP trials completed the recruitment significantly ahead of schedule. I would like to express my sincere gratitude to all members of our clinical operation team, who continue to demonstrate superb clinical operations capability and expertise in the ophthalmology area. Our early completion of recruitment also clearly shows the immense demand and need for a safe and efficacious treatment for myopia progression control in China. Thanks to this achievement, Zhaoke Ophthalmology is hoping to commercialize NVK002 as one of the first low-dose atropine treatments for myopia progression in China, in order to meet this huge unmet need in the country, as well as in South Korea and parts of Southeast Asia.”
NVK002 is an investigational novel topical ophthalmic solution to treat myopia progression in children and adolescents. The drug has a proprietary formulation that successfully addresses the instability of low concentration atropine and has a technology that has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months. According to China Insights Consultancy (CIC), NVK002 is currently one of the most advanced atropine drug candidates globally for myopia progression control and targets the broadest patient group, covering children and adolescents aged 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 for tailoring to the needs of individual patients.
About myopia progression control
Myopia has become a major social issue that plagues the growth of children and adolescents in China. In the “14th Five-Year National Health Plan” issued by the State Council of the Chinese government, clear instructions have been made for the prevention and treatment of myopia in children and adolescents, and strive to reduce the overall myopia rate among children and adolescents nationwide by more than 0.5% per year. The Ministry of Education also issued the “Proposal for Parents of Comprehensive Prevention and Control of Myopia in Children and Adolescents”, calling on parents to pay attention to their children’s eye health.
According to data from the World Health Organization (WHO) and CIC, there are currently approximately 700 million myopia patients in China, 163 million of those are children and adolescents, who may be able to benefit from NVK002. Zhaoke Ophthalmology believes the potential commercialization of NVK002 will allow the Company to establish a leading position in meeting these huge unmet needs in China.
About the Partnership
In October 2020, the Company entered into a license agreement, the NVK002 License Agreement, with Nevakar, which later transferred the agreement to its wholly-owned subsidiary, Vyluma, 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 – Collaborations and License Agreements – License of NKV-002” of the Company prospectus dated April 16, 2021.
For further information about myopia in children, please feel free to listen to Episode 1 of our In Conversation with Zhaoke Podcast here. https://tinyurl.com/wut8fjzm
About Zhaoke Ophthalmology
Founded in 2017, Zhaoke Ophthalmology (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 six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.
Zhaoke Ophthalmology is focusing on advancing toward the goal of product commercialisation, and achieving the objective of improving visual health in China through scientific research as soon as possible.
Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology’s goal is to become a leader in ophthalmology in the world.
For more information, please visit: www.zkoph.com
About Vyluma, Inc.
Vyluma is a development-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 myopia progression in children. NVK002 is currently in late Phase III clinical development in the United States, Europe, and Asia.
Vyluma has a robust pipeline of other assets in various stages of development that 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.
Diana Footitt, CEO
M: +852 9183 0667
Bowen Chui, Director
M: +852 9783 0643
Iris Pei, Director
M: +86 15000 465 016