State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. Surgical methods to treat refractive error by remodeling the cornea, such as laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK), are common in the U.S. An estimated 1.8 million refractive procedures were performed in the U.S. in 2003. Despite its growing popularity, refractive surgery with excimer laser ablation of corneal tissue suffers many limitations. These include over- and under-correction, regression, flap complications, glare, haloes, reduced night vision, diffuse lamellar keratitis, dry eye, and inability to correct predictably large hyperopic and myopic refractive errors. Furthermore, by virtue of removing corneal tissue, these procedures are non-reversible. To provide an alternative to refractive surgery that overcomes many of these limitations, we have made a corneal onlay (implantable contact lens) comprised of a genetically engineered artificial protein. The onlay is placed just underneath the corneal epithelium on Bowman's layer. Once corneal epithelium covers the onlay, it is incorporated into the cornea. Because no corneal tissue is removed, the procedure is reversible. The onlay material contains cell attachment domains derived from elastin and fibronectin, which provide mechanical stability and promote epithelial attachment. Preliminary short-term studies in rabbits implanted with corneal onlays molded from the elastin and fibroncectin-derived artificial protein have established biocompatibility and re-eptihelialization within one week. In the proposed Phase I studies, onlay material will undergo in-vitro purity and toxicity testing, and long-term, in-vivo, pre-clinical testing to determine feasibility for human trials. PERFORMANCE SITE(S) (organization, city, state) Calhoun Vision, Inc.,Pasadena, CA California Institute of Technology, Pasadena, CA Koret Vision Research Laboratory, University of California, San Francisco, CA KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Gary J. Reich, Ph.D. Calhoun Vision, Inc Principal Investigator Shiao Chang, Ph.D. Calhoun Vision, Inc Co-Pi Christian Sandstedt, Ph.D. Calhoun Vision, Inc Director-Optics TBA Calhoun Vision, Inc Chemist David G. Hwant, M.D. Univ of CA, San Francisco Consultant David A. Tirrell, Ph.D. California Institute of Technology Consultant Disclosure Permission Statement. Applicable to SBIR/STTR Only. See instructions. IXI Yes I I No PHS 398 (Rev. 05/01) Page 2 Number pages consecutively at the bottom throughout Form Page 2 the application. Do not use suffixes such as 2a, 2b. Principal Investigator/Program Director (Last, First, Middle): Reich, Gary J. The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT
