FDA grants IDE approval to EyeYon Medical for its US clinical study of EndoArt

The US Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to EyeYon Medical for its US clinical study of EndoArt, which is currently designated by the FDA as a Breakthrough Device.¹

As defined by the FDA, an IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data. Additionally, an approved IDE permits a device to be “shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.”²

EndoArt is an artificial cornea endothelial layer made of a sterile biocompatible material, acrylic hydrophilic. According to the company, it is the first synthetic implant to treat corneal edema. EndoArt attaches to the back of the corneal surface in minimally invasive surgery, preventing the transfer of fluids into the cornea and inhibiting the buildup of fluid that we know as edema.³

The IDE study will be led by Francis Mah, MD, Director of Cornea and External Disease, Scripps Clinic Medical Group, and will include at least 10 cornea surgeons across the US.

Mah commented on the trial, saying, "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.”

EyeYon defines the 7 clinical profiles of patients eligible for the implant as:

• The regraft patient
  • Post-graft failure
• The tubed-eye patient
  • Glaucoma patients with prior drainage implants
• The silicone oil eye patient
  • Vitrectomized eyes or silicone oil-filled eyes
• The tissue shortage patient
  • Patients facing long wait times for human tissue
• The non-donor candidate
  • Patients with cultural or religious restrictions
• The complicated eye
  • Complex ocular history
• The low-visual-potential patient
  • Patients with severe corneal edema outside standard indications

EndoArt is currently CE approved and commercially available in Europe. According to the company, a clinical trial in China has “progressed successfully, reinforcing the device's safety and effectiveness across diverse patient populations.” To date, more than 800 EndoArt implantations have been performed across the globe.

References:

1. EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt, the First Artificial Endothelial Layer for Corneal Edema. Published December 8, 2025. Accessed December 8, 2025. https://www.prnewswire.com/news-releases/eyeyon-medical-ltd-receives-fda-ide-approval-to-initiate-us-clinical-study-of-endoart-the-first-artificial-endothelial-layer-for-corneal-edema-302635250.html

2. The United States Food and Drug Administration. Investigational Device Exemption (IDE). Accessed December 8, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

3. EyeYon—EndoArt. Accessed December 8, 2025. https://eye-yon.com/endoart/