LONG TERM OUTCOMES OF IMPLANTATION OF ARTIFICIAL ENDOTHELIAL IMPLANT FOR THE TREATMENT OF CORNEAL EDEMA

To report twenty-four months safety and efficacy outcomes of an artificial lamellar implantation (EndoArt®) on

the posterior surface of the cornea of adult patients suffering from chronic corneal edema.

Eight of the 17 reported patients were part of FIH study. The implantations were performed in Israel (Rambam Medical Center Haifa and Sourasky Medical Center Tel-Aviv), the Netherlands (UMC, Amsterdam), Germany (Universitäts-Augenklinik, Heidelberg), and in India (LV Prasad Hyderabad). Two reported compassionate cases were performed in Germany (Universitäts Augenklinik, Heidelberg).

The EndoArt® (EyeYon Medical, Ness Ziona, Israel), functions as a water-impermeable layer that is designed to be attached to the recipient’s posterior cornea, preventing the inflow of aqueous humor into the stroma, and decreasing corneal edema. Long-term efficacy and safety data, available for ten patients which took part in a multi-center First in Human study (eight patients) and in early compassionate cases (two patients), is presented. Central corneal thickness (CCT) improvement and stability are discussed. Best corrected visual acuity (BCVA) measured over the 24 months period is presented for patients with visual potential.

A significant improvement in CCT was observed after one month and remained stable over 24 months. Mean preoperative CCT of 791±115μm (702μm - 1087μm) improved to 569±86μm after 24 months,

(n=17, p.value<<0.05). Of 10 patients with visual potential, 9 regained at least 8 ETDRS lines at 24

months. Their vision improved continuosly between 12 and 24 months. One patient returned to baseline BCVA due to consistent partial detachment of the device. 1 patient deteriorated to LP due to optic atrophy. No long-term complications, infections or inflammation related to EndoArt® implantation were observed. Implants remained transparent throughout the follow-up.

The EndoArt® implant was found safe and effective, demonstrating an improvement in corneal thickness as well as in visual acuity. Outcomes of 17 early cases, from the beginning of the learning curve reveal that when fully attached, EndoArt® can alleviate corneal edema and maintain a clear and viable cornea over a long-term period.