SBIR Phase I: Development of a Protein-Based Retinal Implant

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop and commercialize a high resolution, protein-based retinal implant intended to restore vision to the millions of patients suffering from 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. Additionally besides the emotional and physical burden of vision loss, the cost of vision problems in the US alone is estimated at $139 billion. The work outlined in this SBIR proposal has the potential to significantly impact our understanding of retinal degenerative diseases, as well as the field of retinal prosthetics. 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 seeks to quantify the spatial resolution of a flexible, protein-based, ion-mediated retinal implant, as well as to perform an initial evaluation of the implant in vivo. The retinal implant under development is the first implantable technology to use the light-activated protein, bacteriorhodopsin, to convert light energy into an ion gradient that is capable of activating the remaining neural circuitry of the degenerate retina. The retinal implant will replace the function of the damaged photoreceptor cells. Spatial resolution will be evaluated ex vivo using excised retinas obtained from a transgenic rat model of retinitis pigmentosa. Extracellular microelectrode array experiments will be carried out to demonstrate the resolution of the implant, which is critical for meaningful vision. Safety and efficacy of the implant will be evaluated in vivo via a 6-week feasibility study on domestic swine. These in vivo studies are critical to establish the surgical procedures and biocompatibility and biostability of the implant in preparation for long-term, rigorous, preclinical efficacy testing of the implant as part of Phase II investigations. These experiments are critical value creation milestones that will demonstrate the commercial viability of the retinal implant under development.