Sustained Release Inner Ear Delivery of Corticosteroid

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DESCRIPTION (provided by applicant): Cochlear implants have restored hearing in thousands of patients over the last two decades. However, because residual hearing is damaged in the process of insertion, this valuable procedure has been restricted to those patients with profound or total deafness. Many patients with severe hearing loss, a far larger group, are not currently implanted for fear of losing their residual hearing. Steroids have been shown to have a protective effect against hearing loss caused by cochlear trauma. O-Ray's drug delivery technology releases steroids directly from a cochlear implant electrode, decreasing surgery associated inflammation and, in turn, protecting against residual hearing loss. The successful development of O-Ray's cochlear implant for the preservation of residual hearing would have a dramatic impact on hundreds of thousands of patients each year that would now be able to restore hearing using this device. O-Ray's team has demonstrated the safety and efficacy of its steroid releasing cochlear implants in animal models and has produced a prototype device. This Phase IIB proposal is founded on feedback from the FDA and involves the completion of all steps necessary for regulatory approval for the initiation of clinical trials The Specific Aims of this proposal are threefold: First, the Good Manufacturing Practice (GMP) manufacture of O- Ray's cochlear implant electrode with steroid for clinical trials. Second, the characterization of the manufactured steroid eluting electrodes. This will include in vitro tests t assay the physical and chemical properties of the electrode, as well as the stability of the drug in the completed device. Lastly, safety studies of cochlear implant electrode with extended release steroid will be performed to verify the safety of the device for human use. The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has expertise in otology, drug development and drug delivery for the successful development this product. O-Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to three years from a single implantation. At the completion of this work, an IDE will be filed with the FDA for the approval to commence clinical trials. At this point, O-Ray will sell its product to a large cochlear implant company for commencement of clinical trials and introduction of the product to the marketplace.