Inner ear therapeutics for sustained treatment of autoimmune inner ear disease

Project Summary Sensorineural hearing loss is a major medical problem with overmillion Americans affectedThe most common form is presbycusis or aging hearing lossOther types of hearing loss include noise exposuregenetic lossesviral and bacterial infectionsototoxic medicationsautoimmuneand idiopathicThe understanding of the molecular biology responsible for hearing loss is continuing to evolveHoweverthe pathophysiology of many common clinical conditions is still not completely understoodThere is no FDA approved pharmacological agent for treatment of sensorineural hearing lossThis Phase I SBIR proposal involves the fabrication of therapeutic treatments for sensorineural hearing losswith a specific focus on autoimmune inner ear diseaseThe specific aims of this proposal present a roadmap towards the development of intracochlear steroid formulations for the treatment of autoimmune inner ear diseaseThe aims of this proposal are threefoldFirstthe GMP manufacturing of extended release fluticasone particlesSecondsterilization and monitoring of drug release from manufactured particles over aday periodThirdextended release implant formulations will be tested in animal models for safety and drug distribution in the inner earThis will yield prototype implants that will release active therapeutic over the desired three month periodThe team of investigators at O Ray is uniquely qualified to perform the work proposed hereinand has expertise in otologydrug development and drug delivery for the successful development this productO Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinicThis includes an intraocular sustained release steroid implant capable of maintaining anti inflammatory intravitreal drug levels for periods of up toyears from a single implantationPhase II of this project will involve the verifying the stability of these formulationscompletion of chemistry manufacturing and controls for the manufactured particlesand a well controlled safety study and in a suitable animal model in preparation for regulatory approvalThe completion of this work will ultimately facilitate raising follow on venture funding or a collaboration with a corporate partner for the licensing of our developed product Project Narrative Sensorineural hearing loss is a major medical problem with overmillion Americans affectedyet treatment options are limited with no pharmacological agent approved by the FDAThe most common form of hearing loss is presbycusis or aging hearing losswhile other types of hearing loss include noise exposuregenetic lossesviral and bacterial infectionsototoxic medicationsautoimmuneand idiopathicThis Phase I SBIR proposal involves the development of therapeutic treatments for sensorineural hearing losswith a specific focus on autoimmune inner ear disease