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# EyeYon Medical Gets ‘Breakthrough’ for EndoArt
- URL: https://www.fdaweb.com/eyeyon-medical-gets-breakthrough-for-endoart/
- Published: 2020-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:01:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146027

FDA has granted EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant. The polymer film implant is intended to be attached to the posterior corneal surface to treat chronic corneal edema secondary to endothelial dysfunction. A nonfunctioning endothelium results in corneal homeostasis loss due to excess fluid flowing into the cornea, resulting in severe vision loss, the company says. The suture-free EndoArt is designed to replace dysfunctional endothelium in those patients where human donor tissue, which is the current standard of care, has failed to correct the edema, it says. Preclinical and early human clinical studies have demonstrated a significant reduction in edema in affected eyes, it adds.