Prevention of Children's Tympanostomy Tube Otorrhea

Project Summary Otitis media (infection of the middle ear space) is one of the most common diseases of childhood. Myringotomy with tympanostomy tube (TT) insertion is the most common operation performed on children in the United States. Otorrhea is the most common complication following tube insertion and can occur in up to 17% of ears receiving TT and is often associated with active infection. Current treatments involve the administration of antibiotic or antibiotic/steroid drops twice a day for 14 days. Though this decreases the incidence of infection, there are issues with patient compliance and temporary conductive hearing loss in the children. An enhanced treatment option would improve treatment efficacy and increase patient compliance. This CRP SBIR proposal involves the preparation of materials for the initiation of clinical trials for an extended release hydrogel to deliver steroids and antibiotics locally for the treatment of TT associated otorrhea. The aims of this proposal are threefold: First, designing and planning for a Phase 1 clinical trial, including completion of the Investigatorandapos;s Brochure. Second, the development of a regulatory strategy, including compiling documents for submission of an IND, holding a pre-IND meeting with the FDA, and submitting the IND. Lastly, technical assistance associated with manufacturing, specifically identifying contract manufacturers for scale-up of GMP production of material for Phase 2/3 clinical trials. The completion of this project will situate the company for obtaining follow-on funding for the completion of Phase I clinical studies. 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. The next stage of this project will involve the obtaining investment Angel/Venture groups for the initiation of clinical trials.Project Narrative Myringotomy with tympanostomy tube insertion is the most common operation performed on children in the United States and is accompanied by frequent complications of otorrhea, often containing active infection (otitis media). An enhancement over the current treatment option would improve treatment efficacy, increase patient compliance, and eliminate the temporary hearing loss. This CRP SBIR proposal involves the preparation of materials for regulatory approval to initiate clinical trials of therapeutic treatments for otitis media associated with tympanostomy tubes in children.