Phase I resources will be devoted to the research necessary for the construction of TESTCORNEAtm, an in vitro model of the human cornea. This model will be designed for three applications: 1) the determination of the ocular irritancy and cytotoxic potential of chemical, cosmetics, and pharmaceuticals; 2) basic research into elucidating the mechanisms of such toxicity; and 3) basic research into corneal cell biology and wound repair. Organogenesis Inc. has successfully developed an in vitro model of human skin. We now intend to apply our experience in cell culture and tissue engineering to the development of both a rabbit and a human cornea model in vitro. Upon successful completion of Phase I research, Phase II funding will be committed to further develop rabbit TESTCORNEA, and to refine testing methods to be used with this product. During Phase II we will also develop a human TESTCORNEA model which will be designed as a too] to study human corneal cell biology and wound repair. It will also serve as the foundation for the development of a GRAFTCORNEAtm which will be designed as a transplant to replace and/or assist in repair of diseased or injured corneas in humans.Awardee's statement of the potential commercial applications of the research:This product will be used as an alternative to the Draize eye test for the safety testing of cosmetics, chemicals, and pharmaceuticals. It will be used directly by product safety personnel within these industries and also by contract test laboratories. This product will also be used in academic and pharmaceutical research involving corneal cell biology, wound repair and the development of wound repair therapies.National Eye Institute (NEI)