• If approved, NVK-002 could be the world’s first pharmaceutical product for slowing the progression of myopia

• Global data will support regulatory application in China

• Phase III clinical trial testing two different doses 

HONG KONG, 16 July, 2021 – Zhaoke Ophthalmology Limited (“Zhaoke”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs , is pleased to announce today that the investigational new drug (IND) application for phase III clinical trial of its myopia-targeted innovative drug NVK-002 in China, has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China on 14 July, 2021. 

NVK-002 is potentially the world’s first approved ophthalmic solution to control or slow myopia progression. The drug has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of over 24 months. NVK-002 is currently the most advanced atropine drug candidate in clinical development globally for myopia progression control, and targets the broadest patient age group, including children and adolescents ages three to 17 years old. 

The clinical development of NVK-002 involves two different concentrations of preservative-free atropine to determine the efficacy, safety, and tolerability in children and adolescents with myopia.  

Zhaoke Ophthalmology’s licensing partner for NVK-002 is Vyluma Inc., a wholly owned subsidiary of US-based Nevakar Inc. Vyluma is currently conducting the phase III clinical trial for NVK-002 in the US and Europe, to evaluate the efficacy and safety in controlling myopia progression in children and adolescents. The three-year trial results are expected to be available before the end of 2022, followed by a new drug application (NDA) submission to the US Food and Drug Administration (FDA) in 2023.

Upon receiving the IND approval from the CDE, Zhaoke Ophthalmology will also start a phase III bridging clinical trial in China. If NVK-002 is approved by the FDA in the United States, it will be eligible for a real-world study (RWS) in the Hainan Province, in mainland China. The Company plans to combine global data from Vyluma’s phase III clinical trial in the US and Europe with the results of the Company’s clinical trial in China to support an NDA to the NMPA. The treatment will be potentially commercialized for the mainland Chinese market as early as 2024, making Zhaoke Ophthalmology a leader in this area in China.

According to data from the World Health Organization (WHO) and China Insights Consultancy (CIC), there are currently approximately 700 million myopia patients in China, of which about 163 million are children and adolescents. The situation has accelerated given the COVID-19 pandemic and increased time spent on electronic devices, particularly by children and adolescents. CIC suggests that the market size of myopia in China is expected to grow from US$200 million in 2019 to US$3 billion in 2023, at a CAGR of 35.9%.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “Our mission is to transform visual health in China. Myopia is one of the most common eye disorders, impacting hundreds of millions of patients, particularly in mainland China. The risk factors for developing pediatric myopia are mainly genetics, increased screen time and decreased time spent outdoors, leading to an escalation, or even an epidemic, of the disease. We are addressing this need with the world’s first eyedrops shown to be effective in stalling the impacts of myopia in clinical trials. Our product targets the widest age group amongst competitive programs with multiple concentration levels, in an effort to bring benefits to as many patients as possible.”

Dr. Navneet Puri, Chairman and CEO of Vyluma Inc. said, ““We are very pleased our partner Zhaoke has initiated the IND filing for phase III trial of NVK-002 in China. Given the high incidence rate of myopia amongst children and adolescents in China, we believe NVK-002 can potentially bring benefits to tens of millions of patients there. We look forward to working with Zhaoke to advance this trial and position NVK-002 amongst the first wave of low dose atropine approved in China for slowing the progression of myopia in children and adolescents.”