FDA clears first US trial of Israel’s EndoArt synthetic corneal implant
EyeYon Medical says FDA granted IDE for a multicenter study led by Scripps Clinic’s Prof. Francis Mah, with enrolment targeted to begin in March 2026.
By Jerusalem Post Staff, January 11, 2026
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, getting approval to start a clinical trial is a big regulatory hurdle: “It’s an important first step that requires the technology to go through strict testing in the US, including checks for safety, effectiveness, and long-term monitoring. However, based on the EndoArt's performance outside the US during the successful commercial roll-out in the EU and the completed pivotal trial in China, I am confident that the company can meet both safety and efficacy endpoints."
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