XiYi Medical Partners with TopEye Medical and German Ophthalmology Expert to Launch Global Multicenter Clinical Trial for Myopia and Amblyopia Digital Therapy Device

Recently, Xiyi Medical and Shijing Medical have entered into a partnership to conduct international multicenter clinical trials for Shijing Medical’s integrated therapeutic device for myopia and amblyopia. Shijing Medical has engaged in in-depth discussions with the U.S. Food and Drug Administration (FDA) regarding Breakthrough Device designation for this product. The international multicenter clinical trial jointly undertaken by both parties represents the first pre-market international multicenter study in China’s ophthalmic medical device sector. Participating experts span three continents—North America, Europe, and Asia—and come from multiple countries, including the United States, Germany, Poland, Latvia, and Singapore. In the initial phase in Germany, Xiyi Medical is collaborating with Professor Katrin Lorenz, Professor of Ophthalmology and Director of the Clinical Research Center at the University Medical Center of Johannes Gutenberg University Mainz, to advance the implementation of Shijing Medical’s project, thereby supporting Shijing Medical’s expansion into the global ophthalmology market. This strategic tripartite collaboration marks a significant step forward for Chinese innovative ophthalmic technologies in overseas markets and holds promise for delivering more advanced treatment options and hope to patients with myopia and amblyopia worldwide.

Ophthalmic diseases have long been one of the most closely watched medical subspecialties globally, yet innovative therapeutic approaches for eye conditions remain underdeveloped. Among various ophthalmic disorders, refractive errors account for 44%. Globally, myopia affects more than 28.3% of the total population, and the prevalence is projected to rise to 49.8% by 2050, with nearly 5 billion people affected by myopia and approximately 1 billion suffering from high myopia. Since 2017, the global market for ophthalmic devices and pharmaceuticals has maintained a steady growth rate of around 5%, reaching a market size of USD 62.1 billion in 2021. This stable growth trend is expected to continue in the future.

Current interventions for myopia include behavioral interventions, genetic screening, and clinical interventions. Among these, clinical interventions primarily aim at refractive correction, often employing multifocal soft contact lenses, spectacle lenses designed for myopia control, low-concentration atropine, and refractive surgery to manage myopia progression. Although clinical research in ophthalmology has remained a cutting-edge hotspot, there is still a substantial unmet medical need for innovative therapeutic approaches in this field, particularly in myopia prevention and control.

As a leading digital ophthalmology technology company in China, Shijing Medical aims to address the global challenge of myopia prevention and control. Its integrated treatment device for myopia and amblyopia, “Beibele,” incorporates technologies such as VR, VR+, and the Internet of Things (IoT), embedding medical research theories into its product design. This approach will provide users worldwide with an innovative myopia prevention and control solution featuring breakthrough technological advantages.

As the world’s first approved digital therapeutic product for myopia control, Beibeile has undergone multiple iterations and version differentiations. It employs Photobiomodulation Therapy (PBMT) to help control myopia progression. By integrating virtual reality (VR) with patented technologies, it provides accommodative training that simulates viewing objects at both infinite near and far distances, effectively relaxing the ciliary muscle and enhancing or restoring accommodative function. In addition, the system incorporates visual function training to improve the brain’s coordinated control over the eyes, address visual function deficits, and comprehensively enhance binocular visual performance across multiple dimensions.

From a clinical perspective, this red-light myopia treatment device innovatively applies the scleral hypoxia theory to control myopia progression, offering distinct advantages in efficacy, safety, and convenience, and is poised to obtain FDA Breakthrough Device designation.

• Enhanced Efficacy:Superior to the current standard of care (SOC) in controlling axial length elongation and myopia progression, with statistically significant differences in clinical outcomes.

• Excellent Safety Profile: No serious adverse events were reported in randomized controlled trials (RCTs) and real-world studies (RWS), indicating a high safety profile.

Zhou Mosheng, Chairman of Shijing Medicalstated: “Compared with traditional myopia prevention and control methods, digital therapeutics offer advantages in the treatment of myopia and amblyopia, including simplicity and convenience, low cost, a positive user experience, and high adherence. To some extent, they address the pain points associated with conventional treatments. The product Beibele breaks through the limitations of traditional therapies, providing a feasible intervention plan for the prevention, management, and control of myopia in children and adolescents. We are delighted to collaborate with Xi Yi Medicine and Prof. Katrin Lorenz to conduct multicenter clinical trials on myopia and amblyopia. We hope to provide more advanced, efficient, and convenient treatment solutions for patients worldwide in the future, thereby improving their quality of life.”

Dr. Katrin LorenzExpressing great anticipation for this collaboration: “I am highly eager to see the launch of this clinical trial. I believe that through the joint efforts of the three parties, we can achieve significant breakthroughs in the field of ophthalmic treatment and provide more patients with viable intervention strategies for the prevention, management, and control of myopia.”

Mr. Deng Xiaoyu, Founder of Xiyi Medicine“He stated: ‘Shijing Medical’s myopia prevention and control technology is a global leader, offering significant innovative advantages and strong potential for international expansion. By integrating ophthalmology experts worldwide, Xiyi Medicine is jointly supporting Shijing Medical in conducting high-quality global multicenter clinical trials. This effort is expected to further facilitate the entry of innovative Chinese medical devices into the global market and influence treatment guidelines in related fields. Similar to Shijing, original Chinese medical innovations are increasingly going global. Xiyi Medicine looks forward to collaborating with more Chinese medical device companies to benefit patients worldwide and enhance the global accessibility of medical innovations.’” 

Professor Katrin Lorenz earned her Doctor of Medicine degree from the Medical University of Innsbruck. She serves as Professor of Ophthalmology and Director of the Clinical Research Center at the University Medical Center of Johannes Gutenberg University Mainz in Germany. With extensive experience in ophthalmic clinical research, she has participated in numerous multicenter, prospective, controlled clinical trials. Professor Lorenz’s research focuses on ophthalmic clinical studies, particularly in the areas of retinal diseases and diabetic retinopathy. As a member of the German Ophthalmological Society, she is committed to enhancing the standing of German ophthalmology hospitals in the field of clinical research and advancing ophthalmic care through research.

Guangzhou Shijing Medical Software Co., Ltd. is a leading digital technology company in China’s digital ophthalmology sector. It offers innovative solutions such as “Duobaoshi” for the treatment of strabismus and amblyopia in children and adolescents, and “Beibeile” for myopia prevention and control. The company’s independently developed product portfolio includes a telemedicine platform for vision therapy, VR wearable smart devices, eye-tracking technology, an AI-based visual acuity screening system, and an AI-driven intelligent treatment planning system. Over the years, Shijing Medical has kept pace with technological advancements, remaining committed to the research, development, and innovation of its telemedicine platform for vision therapy. Its Duobaoshi Vision Therapy Platform has provided high-quality and effective visual function training to hundreds of thousands of patients, helping more individuals with visual impairments regain healthy vision.

Xiyi Medical is a pharmaceutical and medical device R&D outsourcing company centered on global clinical trials. Leveraging Harvard University’s global medical research resources and academic influence, Xiyi Medical has established a comprehensive overseas service value chain to provide customized global expansion solutions for Chinese biopharmaceutical and medical device enterprises. Its services encompass overseas clinical development strategy and design, overseas clinical trial management and operations, overseas product registration, and overseas commercialization layout. Since its inception, Xiyi Medical has successfully facilitated the overseas launch of more than 50 biopharmaceutical and medical device projects, generating cumulative overseas profits exceeding RMB 16 billion for its clients. Currently, Xiyi Medical employs an in-house overseas clinical trial team of over 100 professionals, collaborates with more than 2,000 experts, and has partnerships with over 100 renowned overseas hospitals, covering regions including the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, and Africa.

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