Endoart Implantation In Patients At High Risk For Human Graft Rejection

To report six months 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.

27 patients are reported. 9 participated in the phase II clinical trial, in France (Hôpital Fondation de-Rothschild - Paris), Georgia (Mzera and DaVinci) and India (LV Prasad). 7 patients were part of a compassionate study in China (Beijing 3^rd Hospital). 9 cases were following commercialization in Italy (s.Orsola Hospital), Belgium (Antwerp University Hospital) and Israel (Soroka). 1 patient was part of the FIH in Israel (Assuta Medical Center), and 1 in Georgia (DaVinci)

The EndoArt® (EyeYon Medical, Ness Ziona, Israel) was implanted in 27 high- risk patients. These patients either failed multiple keratoplasties or had a condition placing them at risk for human graft failure. Thirteen of the 27 were operated as part of a clinical trial, 8 were compassionate cases and additional 6 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 6 months post implantation.

Significant improvements were observed: Mean CCT decreased from 793±231μm (n=27) to 593±173 μm at 6-month follow-up (n=22, p-value<0.05). Pain (VAS score), was markedly reduced from 18±18 pre-op (n=18) to 1±3 at 6 months post implantation (n=17, p-value<0.05). The average improvment in BCVA was 3.2 lines of ETDRS (n=24). Despite 38% of the patients having low visual potential, BCVA improved in 58.3% at 6-month 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. One device was removed at 3- months follow-up due to insufficient attachment to the cornea and was replaced by DSAEK.

The EndoArt® 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. EndoArt®, as a synthetic implant, is not subjected to rejection, and may provide a long- term solution for high-risk patients.