EndoArt^®: Artificial Endothelial Implant

When I was an ophthalmology resident, I found myself wondering why we had synthetic substitutes for the crystalline lens but not for the cornea. For patients with corneal edema, access to treatment can be a waiting game, depending on the availability of donor tissue. This realization ultimately led to the founding of EyeYon Medical and the creation of EndoArt^®: the world’s first artificial endothelial implant.

Redefining the Treatment Paradigm

The idea of EndoArt emerged from my clinical observation that patients in whom silicone oil had leaked from the vitreous cavity into the anterior chamber did not develop corneal edema despite a low endothelial count. The silicone oil acted as a barrier, decreasing the amount of aqueous humor reaching the cornea, thereby inhibiting the development of corneal edema. This observation led to the invention of EndoArt.

EndoArt is a 6.5-mm, 50-µm–thick implant that creates an impermeable barrier to fluid ingress, effectively reducing stromal hydration and restoring corneal clarity. The device, a biocompatible, biostable hydrophilic acrylic polymer, is implanted into the posterior corneal surface via a minimally invasive procedure. This material (the same commonly used in IOLs) ensures long-term biocompatibility and eliminates the risk of immune rejection. EndoArt’s attachment mechanism of action is based on a two-stage adhesion process: a gas bubble initially positions and holds the implant through surface tension, followed by stromal tissue adhesion that occurs naturally within the first 3–7 days after implantation.

Surgical Advantages

Surgically, EndoArt procedures resemble endothelial keratoplasty (EK) but are technically simpler. Surgeons familiar with DSEK or DMEK will find the process intuitive. Unlike donor tissue, the implant has a long shelf life, is ready to use out of the box, and eliminates the need for immunosuppressive therapy. The device can be repositioned or removed and reimplanted without the fear of losing endothelial cells (as with human tissue), providing flexibility intraoperatively and for postoperative management.

EndoArt implantation takes 20 minutes in the OR, followed by 4 hours of lying supine. We also provide clear patient guidelines to maximize outcomes.

Clinical Efficacy and Long-Term Safety

EndoArt is a clinically proven solution with over 600 implantations, 6 years of follow-up, and regulatory approval in Europe (CE mark under MDR approval) and a few other regions.

Among key clinical findings:

• In phase 1 and phase 2 studies, EndoArt has demonstrated a strong safety profile, with no device-induced inflammation or long-term complications reported to date.¹
• 68% visual acuity improvement at 12 months (n = 63).¹
• In an ongoing study in China, 71% of patients’ visual acuity improved by 6 lines or more (n = 32).
• In a premarket study, mean corneal thickness decreased from 793±108 µm preop to 565±110 µm at 1 year, and 577±89 µm at 2 years (n = 21).²

The EndoArt has been granted Breakthrough Device Designation by the FDA, recognizing its potential to offer a more sustainable treatment for patients with corneal edema compared to existing alternatives in patients at high risk for human tissue rejection. We’ve secured IDE approval for a clinical study in the U.S. as part of the approval process. Our clinical studies and commercial phase demonstrate that EndoArt achieves visual improvement in most patients, bringing hope, especially to those who have repeatedly rejected human tissue.

Who Is It For?

EndoArt offers a transformative alternative to donor tissue in complex cases. It is an ideal option for eyes with multiple graft failures, high-risk conditions like glaucoma drainage devices, or immune sensitization. It addresses the needs for those patients who are repeatedly rejecting human tissue transplants and are in the “re-graft cycle.” We are also exploring additional use cases for EndoArt.

In countries with limited access to donor corneas, EndoArt offers a scalable, standardized solution. With simpler logistics, easier surgical training (6–7 cases versus ~50 for standard keratoplasty), plus 3 years shelf life and no refrigeration requirements, we envision the possibility of EndoArt revolutionizing corneal blindness care globally.

1. EndoArt data from phase I & II clinical studies and PMS, new implantation protocol, May 21st, 2024.

2. EndoArt data on file, 2024.

For more information: https://eye-yon.com/

For inquiries, contact: Anat Lemze, Director of Medical Affairs anat@eye-yon.com