The US Food and Drug Administration (FDA) has granted Breakthrough Status designation to EyeYon Medical’s artificial endothelial layer implant EndoArt.
EndoArt, made of polymer film, attaches to the posterior corneal surface to treat chronic corneal oedema secondary to endothelial dysfunction.
When endothelium does not function, it leads to corneal homeostasis loss due to excess fluid flowing into the cornea, leading to severe vision loss.
EyeYon Medical CEO and co-founder Nahum Ferera said: “Receiving Breakthrough Device Designation for our revolutionary EndoArt implant is an important milestone in accelerating the path to the market, affecting the quality of life of millions of patients.
“We look forward to collaborating with the FDA to speed the clinical development of EndoArt so that it can be used to treat a condition that impacts the lives of so many.”
EndoArt is minimally invasive and suture-free, designed to replace dysfunctional endothelium in patients where human donor tissue has failed to cure oedema.
According to the company, both preclinical and early human clinical studies indicated a significant reduction in oedema in affected eyes.
Currently, there is no adequate solution for patients with corneal oedema other than undergoing corneal transplant surgery.
Globally, 13 million affected patients are waiting for corneal tissue. The company claims a significant number of patients would benefit if approved from EndoArt development.
EyeYon Medical develops medical ophthalmic devices. Its first product was Hyper-CL therapeutic contact lens to treat various corneal pathologies, such as corneal oedema and erosions. Hyper-CL lens received the CE Mark and FDA clearance for marketing in Europe and the USA.