SBIR Phase II: Design and Optimization of a Biocompatible Protein-Based Retinal Implant for the Treatment of End-Stage Retinal Degeneration

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop and commercialize a high resolution, protein-based retinal implant intended to restore vision to the millions of patients blinded by retinal degenerative diseases, particularly retinitis pigmentosa and age-related macular degeneration. These currently incurable and blinding diseases affect between 30-50 million people worldwide, and lead to a loss of independence for the individual, as well as an increased burden on their caregivers. While improved quality of life is the most vital outcome of this technology, reduction of medical costs of treating chronic retinal degeneration and limiting time with doctors will also be of benefit to the broad healthcare field. The work outlined in this SBIR proposal also has the potential to significantly impact our understanding of retinal degenerative diseases, which will help in developing better and more effective treatments for a number of ophthalmic indications. The subretinal implant under development provides the framework for the next generation of high-resolution retinal prosthetics, while offering a cost-effective solution to vision restoration, and will help these patients regain independence and thus improve their quality of life. The proposed project will expand on the data collected from the in vivo surgical development and ex vivo efficacy studies supported by our Phase I/IB awards. First, a 40-animal rat study will be undertaken to further investigate the biocompatibility of the retinal implant. Second, previously developed surgical procedures will be refined in pigs to ensure reproducible and safe subretinal implantation. Third, a high-throughput in vitro assay will be designed to investigate a number of implant parameters, as well as the integrity and biostability of the retinal implant using retinal pigment epithelial cells. Additionally, medical device sealants will be investigated in this in vitro study, and the functional integrity of the implant will be measured using time-resolved absorption spectroscopy and an ion-sensitive detector, which is being developed specifically for this application. Lastly, this ion-sensitive detector will provide an opportunity to further measure the spatial sensitivity of the retinal implant with high resolution. These in vivo and in vitro studies are vital for the continued evaluation of biocompatibility, surgical feasibility, and efficacy of the implant. The results from these studies will further demonstrate the commercial viability of the technology under development.