Project Summary
Sensorineural hearing loss is a major medical problem with over 32 million Americans affected. The most
common form is presbycusis or aging hearing loss. Other types of hearing loss include noise exposure, genetic
losses, viral and bacterial infections, ototoxic medications, autoimmune, and idiopathic. The understanding of
the molecular biology responsible for hearing loss is continuing to evolve. However, the pathophysiology of
many common clinical conditions is still not completely understood. There is no FDA-approved
pharmacological agent for treatment of sensorineural hearing loss.
This Phase I SBIR proposal involves the fabrication of therapeutic treatments for sensorineural hearing loss,
with a specific focus on autoimmune inner ear disease. The specific aims of this proposal present a roadmap
towards the development of intracochlear steroid formulations for the treatment of autoimmune inner ear
disease. The aims of this proposal are threefold: First, the GMP manufacturing of extended release fluticasone
particles. Second, sterilization and monitoring of drug release from manufactured particles over a 90 day
period. Third, extended release implant formulations will be tested in animal models for safety and drug
distribution in the inner ear. This will yield prototype implants that will release active therapeutic over the
desired three month period.
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 3 years from a single implantation. Phase II of this project will involve the
verifying the stability of these formulations, completion of chemistry manufacturing and controls for the
manufactured particles, and a well-controlled safety study and in a suitable animal model in preparation for
regulatory approval. The 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.