EyeYon Medical Ltd. announced on December 8 that the US Food and Drug Administration had granted Investigational Device Exemption (IDE) approval to initiate a US clinical study of EndoArt, which the company described as the world’s first synthetic endothelial layer for the treatment of chronic corneal edema. The FDA currently designates the device as a Breakthrough Device, the company said.
The study will be led by Francis S. Mah, MD, Director of Cornea and External Disease at Scripps Clinic Medical Group, and is expected to include at least 10 cornea surgeons across surgical centers nationwide, according to the company’s statement.
“The initiation of this US clinical study marks an exciting moment for our field,” Mah said in the announcement, calling EndoArt “a truly novel approach” to treating chronic corneal edema.
A path to long-term corneal clarity and stability
EyeYon CEO Nahum Ferera said the IDE approval was “a pivotal milestone” for patients suffering from corneal endothelial diseases, which he said represented a global market exceeding $1 billion. He added that EndoArt had seen adoption in Europe, and that the US study could advance an option for patients who are not reasonable candidates for human tissue implantation in the US.
EyeYon said EndoArt has been evaluated in multiple clinical studies outside the United States and has received a CE mark in Europe. The company said a dedicated clinical trial has progressed in China, and that more than 800 EndoArt implantations have been performed worldwide with up to seven years of follow-up data cited by the company as showing long-term corneal clarity and stability.
In the United States, EndoArt remains an investigational device and is limited to investigational use, the company said, adding that it is not available for sale in the US.