EyeYon Medical Ltd. announced that the US Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval to initiate a US clinical study of EndoArt, according to a company-issued press release. EndoArt is a synthetic endothelial layer for the treatment of chronic corneal edema that is currently designated by the FDA as a Breakthrough Device,according to EyeYon Medical Ltd.
The study will be led by Professor Francis Mah, MD, director of Cornea and External Disease, Scripps Clinic Medical Group. The clinical investigation will include at least 10 leading US cornea surgeons across surgical centers nationwide.
According to the company, the EndoArt has been evaluated in multiple clinical studies outside the US and has received a CE mark. In Europe, the technology has seen a steadily expanding commercial rollout, with growing surgeon adoption. In China, a dedicated clinical trial has progressed successfully, reinforcing the device's safety and effectiveness across diverse patient populations, the company said. To date, EyeYon Medical said, more than 800 EndoArt implantations have been performed worldwide, supported by up to 7 years of follow-up data showing long-term corneal clarity, stability, and sustained therapeutic benefit.