ENDOART IMPLANTATION IN PATIENTS AT HIGH RISK FOR HUMAN GRAFT REJECTION

To report 12 (twelve) months of safety and efficacy outcomes of implantation of an impermeable artificial lamella (EndoArt) on the posterior surface of the cornea of adult patients suffering from chronic corneal edema who were at high risk for human graft rejection.

The EndoArt® (EyeYon Medical, Ness Ziona, Israel) was implanted in 35 high-risk patients. This study involved a retrospective data collection from the first-in-human study, Phase 2 EndoArt trial, and post-marketing surveillance.

35 high-risk patients. These patients either failed multiple keratoplasties or had a condition placing them at risk for human graft failure. 17 (Seventeen) of the 35 were operated as part of a clinical trial, 13 were compassionate cases, and 5 patients were implanted with EndoArt following CE approval. Safety and efficacy data, including central corneal thickness (CCT), best corrected visual acuity (BCVA), and pain score (measured by visual analogue scale, VAS), are presented for the first 12 months post-implantation

86% (Eighty-six percent) of the patients presented alleviation of corneal edema. Mean CCT decreased from 792±203 μm (n=35) to 606±158 μm at 12-month follow-up (n=23, p-value<<0.05). Pain (VAS score) was markedly reduced from 17±19 pre-op (n=22) to 4±8 at 12 months post-implantation (n=15, p-value<<0.05). Despite 24% of the patients having low visual potential, BCVA improved in 65% at the last follow-up. There were no long-term complications, nor reports of infections or inflammation related to EndoArt implantation. The implants remained transparent throughout the follow-up. Three devices were removed due to insufficient attachment and replaced with tissue. One patient developed a non- related fungal infection, and the implant was replaced with PK.

 The implant was found to be a safe and effective treatment for chronic corneal edema in patients at high risk for human graft rejection, reducing edema and pain and improving vision in most patients. It is not subjected to rejection and may provide a long-term solution for high-risk patients.