About 4 to 8 thousand people yearly in the U.S. suffer blinding corneal disease not amenable to conventional keratoplasty. The improved keratoprosthesis (KPro) may restore functional vision for these people, and is the basis for a significant demand supporting commercialization. This Phase I project involves developing an improved thinner KPro of PMMA that, with a significant innovative process, can be more securely fixated to a donor cornea for use as a standard graft. The measurable goals are: 1) developing a KPro production methodology to produce powers within +0.5D accuracy; 2) demonstration of the fusion of front and back flanges with a narrow gap of 0.5-0.7mm with strength of 50 Newtons; 3) an independent laboratory determination of bioburden and ethylene oxide sterilization validation, and toxicology testing. Reaching these endpoints will permit processing directly to a Clinical Trial in Phase II project under FDA Guidance Document for Keratoprostheses. Tamcenan Corporation, and the Principle Investigator have experience in developing and securing regulatory clearence and comericalization of ophthalmic implants. Engineering & Ophthalmic Services has experience in devising manufacturing protocols for contact lenses and Kpros. Geneva Laboratories, Inc. is a full service certified testing laboratory that follows accepted protocols for required tests.
The estimated 4 to 8 thousand patients in the U.S. yearly that cannot be adequately served by standard keratoplasty or existing KPros form a significant market for commercialization of a product that costs between $500.00 and $1000.00. The participation of Eye Banks in this project will aid distribution and increase rewards for those participating.
