FDA Grants IDE Approval for EndoArt Synthetic Endothelial Layer US Clinical Study

The FDA’s Investigational Device Exemption (IDE) approval allows EyeYon Medical to launch its first US clinical study of EndoArt, which the company describes as the world’s first synthetic endothelial layer for patients with chronic corneal edema. The device holds FDA Breakthrough Device designation, highlighting its potential clinical impact for individuals with corneal endothelial dysfunction.

Study Leadership and Design

The US clinical study will be led by Prof. Francis Mah, MD, Director of Cornea and External Disease at Scripps Clinic Medical Group.

Key facts include:

• Participation from at least 10 leading US cornea surgeons

• Multi-center involvement across the United States

• Focus on safety, anatomical outcomes, and visual recovery

• First US evaluation of EndoArt’s performance in real-world clinical practice

Prof. Mah emphasized the significance of the trial, noting that EndoArt may “reshape the future of endothelial disease management.”

EyeYon Medical Highlights Market Need and Global Momentum

Nahum Ferera, CEO of EyeYon Medical, underscored the importance of the IDE approval, noting the global market for corneal endothelial diseases exceeds $1 billion.

He stated that the US study represents a major advancement toward offering a non-tissue-based alternative for patients who are unsuitable candidates for human endothelial grafts.

EndoArt has already demonstrated strong early commercial adoption in Europe, where surgeons have integrated the technology into practice following CE mark approval.

What Is EndoArt? A Synthetic Approach to Endothelial Disease

EndoArt is a synthetic endothelial implant that functions as a barrier layer on the posterior cornea, designed to reduce corneal swelling and restore clarity.

Key features: - Eliminates reliance on donor-derived corneal tissue, helping address global graft shortages - Minimally invasive implantation compared to traditional endothelial keratoplasty - Intended for patients with chronic corneal edema and endothelial dysfunction.

International studies have evaluated the device’s safety and performance, contributing to regulatory clearance in Europe and growing adoption in clinical practice.

Global Clinical Progress and Long-Term Outcomes

EyeYon reports substantial international progress:

• 800+ EndoArt implantations performed worldwide

• Clinical follow-up extending up to 7 years

• Outcomes reported include:

• Long-term corneal clarity

• Anatomical stability

• Sustained reduction in corneal edema

• Durable therapeutic benefit across diverse populations

In China, a dedicated clinical trial has advanced successfully, further validating the device’s safety and efficacy.

Implications for US Corneal Care

If US clinical results mirror international findings, EndoArt may emerge as a transformative option for patients who are poor candidates for donor endothelial transplantation. The IDE authorization marks a major step toward expanding treatment pathways for chronic corneal edema in the United States.

Conclusion

EyeYon Medical’s FDA IDE approval initiates a pivotal chapter for EndoArt’s clinical evaluation in the United States. With strong international data and increasing global adoption, the upcoming US study may define the device’s future role in treating endothelial dysfunction. Patients should consult their eye-care specialists for personalized guidance regarding treatment options.