EyeYon Medical, an Israeli company that makes devices for eye treatments, announced that the US Food and Drug Administration (FDA) has allowed them to start the first human clinical trial in the US for EndoArt, a synthetic corneal implant designed for chronic corneal edema. The multicenter study, led by Prof. Francis Mah of Scripps Clinic, is expected to launch in March 2026 across several US surgical centers, according to the company.
The trial will evaluate safety, effectiveness, complications, and long-term performance, with participation from at least ten leading corneal surgeons nationwide, the company said. Prof. Mah was named principal investigator.
What the device does
EndoArt is designed to restore corneal clarity by replacing the function of the endothelium, the cornea’s innermost layer, without relying on donor tissue. The Jerusalem Post previously reported the FDA cleared an IDE for EndoArt and listed it under the Breakthrough Device program.
The IDE permits clinical testing in humans in the United States. It does not confer marketing authorization. EyeYon says EndoArt is intended to proceed through the FDA’s PMA route, the most rigorous pathway for novel devices.
The implant has seen controlled use in Europe and Israel.
According to EyeYon Medical CEO Nahum Ferera, this is a considerable regulatory challenge: “Approval to initiate a clinical trial is a necessary but early stage, subjecting the technology to rigorous clinical evaluation under American conditions, including requirements for safety, effectiveness, and long-term follow-up.”