EyeYon Receives FDA IDE

EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt®, the First Artificial Endothelial Layer for Corneal Edema

December 8, 2025
8:01 pm

NES ZIONA, Israel, Dec. 8, 2025 /PRNewswire/ -- EyeYon Medical Ltd., a global leader in ophthalmic innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a U.S. clinical study of EndoArt®, the world's first synthetic endothelial layer for the treatment of chronic corneal edema. EndoArt® is currently designated by the FDA as a Breakthrough Device.

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 U.S. cornea surgeons across surgical centers nationwide.

“The initiation of this U.S. clinical study marks an exciting moment for our field. EndoArt represents a truly novel approach to treating chronic corneal edema. I’m honored to lead this important investigation and to help evaluate a technology that may reshape the future of endothelial disease management,” said Prof Francis Mah.

EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt®, the First Artificial Endothelial Layer for Corneal Edema

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