EyeYon Medical's EndoArt Receives FDA Approval for Study in Corneal Edema Treatment

EyeYon Medical Secures FDA Approval for EndoArt Studies

EyeYon Medical Ltd., an innovative force in the ophthalmic sector, has announced a significant milestone with the receipt of Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This approval will allow the company to initiate a clinical study in the U.S. for EndoArt®, the first synthetic endothelial layer specifically designed to treat chronic corneal edema.

The EndoArt® device is not only notable for its innovative design but has also been awarded the prestigious Breakthrough Device designation by the FDA. This recognition underscores its potential impact in addressing a pressing medical need, as chronic corneal edema is a condition affecting a substantial number of patients and often requires advanced treatment options.

The clinical study will be spearheaded by Professor Francis Mah, MD, who is the Director of Cornea and External Disease at Scripps Clinic Medical Group. The study aims to include at least ten top U.S. cornea surgeons, ensuring a comprehensive evaluation of the technology across several surgical centers nationwide. Professor Mah expressed enthusiasm about leading such an important investigation, indicating that EndoArt® represents a transformative approach to manage endothelial disease. He stated, "This trial could significantly change the future landscape of treatment for corneal edema patients."

Nahum Ferera, the CEO of EyeYon Medical, highlighted the importance of this IDE approval by emphasizing its role as a pivotal milestone for both the company and patients grappling with corneal endothelial diseases. With the global market for such conditions exceeding $1 billion, the FDA's approval opens up new possibilities. Ferera remarked, "EndoArt has gained traction in Europe and this U.S. study brings us closer to offering a novel solution for patients who are unsuitable candidates for traditional human tissue transplantation."

Redefining Treatment for Corneal Edema

The EndoArt® implant has previously been evaluated in various clinical studies outside the U.S. and already boasts a CE mark, enabling its commercial rollout in Europe where it has seen increasing adoption among surgeons. In China, promising results from dedicated clinical trials have reaffirmed the device's safety and efficacy across diverse patient demographics. To date, over 800 implantations of EndoArt have been successfully performed worldwide, bolstered by extensive follow-up data spanning up to seven years. This data illustrates consistent long-term improvements in corneal clarity and stability.

These developments place EndoArt® as a revolutionary option within the global corneal care landscape, offering new hope to patients faced with the debilitating effects of corneal edema. EyeYon Medical is dedicated to addressing one of ophthalmology's most significant unmet needs, providing innovative and accessible solutions for corneal diseases.

As the impending U.S. clinical study progresses, the medical community will watch closely, hoping for favorable outcomes that could herald a new era in the treatment of corneal conditions. With its innovative technology, EyeYon Medical is set to redefine how chronic corneal edema is managed, ultimately improving patient care and outcomes.