The corneal endothelial cells pump fluids out from the cornea keeping hydration levels normal and vision clear and are irreplaceable as they are rarely divided, and do not regenerate once damaged. Their damage due to trauma or disease results in corneal edema that may cause in loss of transparency of the cornea, and even blindness. To date, 13 million people expect a cornea transplant globally; in 40% of them the transplant is necessary due to endothelial function failure. EyeYon Medical has developed the EndoArt® (Artificial Endothelial Layer) implant, a biocompatible silicon disc that adheres to the endothelium of the posterior corneal surface, preventing the transfer of fluids into the cornea thus alleviating the disease. The CORI project aims to further develop this technology with the improvement of the adhesion properties of the EndoArt® implants with the use of laser surface patterning and/or plasma polymerization to produce different nanostructured coatings. The improvement of the adhesion properties of the implants will be validated in vitro using corneal endothelial cells and stromal cells lines and in vivo in a preclinical animal study. Using the rabbit model of Cornea Bullous Keratopathy endothelial injury in vivo we will examine whether the EndoArt® implants with enhanced adhesion properties may alleviate the disease. The envisaged outcomes from the CORI project will be a modified EndoArt® implant by two different micro-nano strategies in order to improve its existing adhesiveness to the tissue for a long time (lifetime) with minimal chance for detachment leading to reduced need for cornea transplant. Thus the target market of the implant is the global market for treating corneal problems which each year has about 2 million new cases of corneal edema, with approximately 0.5 million of them requiring a cornea transplant.
To meet the challenges of the CORI project, we define the following general objectives:
- To develop corneal implants with improved adhesion properties following two different strategies for adhesion enhancement, including surface structuring complemented with nanostructured coatings.
- To validate the increased adhesion properties of the corneal implants in vitro
- To validate the effectiveness of the corneal implants to alleviate corneal edema without inflammatory response and damaging the endothelium in an in vivo preclinical animal study (rabbit).
- To show the advantage and added value resulting from the cooperation between the participants from the two countries in terms of: i) access to R&D infrastructure for the micro-nano patterning of the surface of the corneal implants, ii) increase knowledge base in terms of adhesive properties of new implants in the cornea area; iii) commercial leads for the Israeli company e.g. new product and the Greek company e.g. established surgical procedure and implantation of the new products.