EyeYon Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its EndoArt polymer film implant.

EndoArt, which is an artificial endothelial layer, is fixed to the posterior corneal surface for the treatment of chronic corneal edema secondary to endothelial dysfunction.

An endothelium that has become nonfunctional leads to corneal homeostasis loss due to excess fluid flowing into the cornea, which may result in severe vision loss.

The minimally invasive and suture-free EndoArt will  replace dysfunctional endothelium

EyeYon has designed the minimally invasive and suture-free EndoArt to replace dysfunctional endothelium in the patients where human donor tissue does not resolve the edema.

According to the company, both preclinical and early human clinical studies have shown a significant reduction in edema in affected eyes.

EyeYon also said that there is no effective solution for patients suffering from corneal edema and around 13 million patients are looking for corneal tissue across the globe.

The company delivered the FDA with information showing that the proposed indication “treat corneal edema in patients with chronic corneal edema due to endothelial dysfunction in whom prior endothelial keratoplasty has failed and/or who is not a reasonable candidate for corneal transplantation”, meets the regulator’s criteria.

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, effecting 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 which impacts the lives of so many.

In November 2019, CooperVision secured approval from the FDA for its MiSight contact lens to delay the progression of myopia in children.

The contact lens has been developed to slow the progression of myopia in children between the ages of 8 and 12 years old at the initiation of treatment.