Development of Artificial, Collagen Based Corneal Grafts

The objective is to develop an artificial full-thickness corneal graft to replace damaged corneain millions of people who suffer from blindness due to damaged or diseased cornea. The specific aimsof Phase I are to fabricate prototype grafts composed of a clear, soluble collagen core surrounded by aperipheral ring, or skirt, containing' intact collagen fibers embedded in soluble collagen. Preliminaryevaluations in the rabbit model have demonstrated biocompatibility, rapid healing of the host-graftjunction, variable re-epithelialization, and reasonable optical stability. However, additional developmentis needed to improve and demonstrate optical and biological stability of the optic core, provide consistentreepithelialization of the entire graft, and show long-term biocompatibility in animal models. Results fromPhase I will lead to more extensive and longer-term evaluations in animal models. These results will benecessary for submitting appropriate applications to FDA to initiate phased, human clinical trials.