Keratoprosthesis

Corneal diseases are considered the second most important cause of blindness today. While corneal transplantations are often performed successfully, the use of a keratoprosthesis, an artificial cornea, is offering an alternative for all those patients where a donor’s tissue graft is not accepted.

TBMED partners AJL and CID are collaborating closely on the implementation of the AlphaCor keratoprosthsis for long-term retention. AlphaCor is a biocompatible, flexible, one-piece synthetic cornea made from poly(2-hydroxyethyl methacrylate) that has a peripheral region with interconnecting pores allowing bio-integration with surrounding corneal tissue. The entire device has surface curvatures that result in appropriate refractive power when implanted. It is placed within a lamellar corneal pocket and the porous skirt remains enclosed within the corneal stromal tissue with which it bio-integrates because of cellular colonization and collagen deposition.

Development in TBMED using potential OITB services

The QbD approach is applied to the design and production of TBMED keratoprosthesis to achieve a controlled, reproducible and safe medical device as well as a safe and robust production process. A pilot production will be used to pre-clinically validate the advanced keratoprosthesis ensuring safety and efficacy of the keratoprosthesis in a quicker and cheaper way than using conventional methodologies. In a final step during TBMED, pilot clinical testing will be initiated and demonstrate the clinical proof of concept with a small number of humans under carefully controlled and intensely monitored clinical conditions.