Super Vision Technology's i-NYS Implant Receives China Approval as World's First Treatment for Congenital Nystagmus
核心洞察
Super Vision Technology (搜索)'s i-NYS (搜索) implantable device has received market approval from China's NMPA, becoming the world's first approved treatment for congenital nystagmus (搜索), a condition previously considered incurable in ophthalmology.
The device uses microcurrent stimulation to regulate extraocular muscle (搜索) movement and has demonstrated efficacy in multi-center clinical trials involving 71 patients, significantly improving visual function and quality of life.
Congenital nystagmus (搜索) affects approximately 1.3 million patients in China and 7 million globally, with the condition manifesting between 3-6 months after birth and persisting for life.
Super Vision Technology (搜索) has achieved a groundbreaking milestone in ophthalmology with the approval of its i-NYS (搜索) (Extraocular Neuromuscular Stimulator Implant) by China's National Medical Products Administration (NMPA). The device, officially authorized for commercialization in China with Registration No. 20263120535, represents the world's first implantable treatment for congenital nystagmus (搜索), a condition long regarded as one of the most challenging to treat in ophthalmology.
Addressing an "Incurable" Condition
Congenital nystagmus (搜索) involves involuntary, rhythmic, to-and-fro oscillations of the eyes that typically manifest between 3-6 months after birth and persist for life. Patients experience varying degrees of visual impairment, binocular visual dysfunction, and abnormal head position. With no significantly effective treatment previously available, the condition has been considered "incurable" in ophthalmology.
The disease burden is substantial, with prevalence rates between 1‰-3‰ in the general population. The incidence among preterm infants is approximately six times higher than in full-term infants. Current estimates indicate about 1.3 million patients in China and roughly 7 million globally are affected by this condition.
Revolutionary Treatment Mechanism
The i-NYS (搜索) device represents a novel therapeutic approach developed by Super Vision Technology (搜索) based on research by Professor Wang Lejin from the Ophthalmology Department of Peking University People's Hospital. The implantable extraocular neuromuscular stimulator fundamentally intervenes in the pathological rhythm of nystagmus by using microcurrent stimulation to regulate extraocular muscle (搜索) movement.
Clinical trial data demonstrates the efficacy and safety of i-NYS (搜索) for congenital nystagmus (搜索). The device significantly increases patients' macular foveal fixation time, reduces nystagmus amplitude and frequency, and shows favorable long-term prognosis, thereby improving patients' visual function and quality of life.
Two-Decade Development Journey
The i-NYS (搜索) device represents the culmination of over 20 years of innovative research and development by Professor Wang Lejin's team. The development timeline showcases the extensive validation process required for this breakthrough technology:
The clinical concept was first proposed in 2004, with IIT clinical validation completed in 2015. In January 2024, i-NYS (搜索) entered the NMPA's "green channel" for innovative medical device review. Multi-center clinical trials in China and one-year follow-up were completed in October 2024, involving 45 adult and 26 pediatric patients at Beijing Chaoyang Hospital (搜索), Beijing Tongren Hospital (搜索), and Beijing Children's Hospital (搜索).
The device received Humanitarian Use Device (HUD) designation from the US FDA in June 2025, before achieving final market approval from the NMPA on March 13, 2026.
Global Impact and Innovation
As the world's first and only approved Class III active implantable medical device for treating congenital nystagmus (搜索), i-NYS (搜索) was independently developed by a Chinese research team. The approval not only brings hope to patients with congenital nystagmus but also highlights significant progress in the development of innovative therapies within China's ophthalmology field.
Super Vision Technology (搜索), the company behind this breakthrough, is a global high-end ophthalmic medical device and medical microchip R&D company. The company focuses on multiple cutting-edge technological fields, with core research areas including implantable neuromuscular electrical modulation technology, innovative crosslinking biomechanical modulation technology, AI-based image recognition in ophthalmology, and "visual reconstruction" brain-computer interface technology.