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 Phase II SBIR proposal involves the validation of manufacturing and safety of therapeutic treatments for otitis media associated with tympanostomy tubes in children.
The specific aims of this proposal present a roadmap towards the development of an extended release hydrogel to deliver steroids and antibiotics locally for 14 days.
The aims of this proposal are threefold: First, manufacturing of the components of the extended release hydrogel using FDA guidelines for GMP manufacturing for Phase 1 clinical trials will be done. Second, the sterility and stability of the components of the extended release hydrogel will be tested. Lastly, a well- controlled study assessing the safety of the extended release hydrogel and its components will be performed under Good Laboratory Practice conditions. The completion of this project will finish all preclinical studies required for the initiation 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 collaboration with a corporate partner for the licensing of our developed product and the initiation of clinical trials.
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 Phase II SBIR proposal involves the validation of manufacture and safety of therapeutic treatments for otitis media associated with tympanostomy tubes in children.
