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, increase patient compliance, and eliminate the temporary hearing loss. This Phase I SBIR proposal involves the fabrication of therapeutic treatments for otitis media associated with tympanostomy tubes in children.
The specific aims of this proposal present a roadmap towards the early stage development of an extended release hydrogel to deliver steroids and antibiotics locally for 14 days.
The aims of this proposal are threefold: First, the development of prototype extended release composition of the therapeutic formulation to incorporate the desired therapeutic dose and release duration. Second, the development of an injectable hydrogel containing these extended release drugs. Third, the activity of the release therapeutics will be analyzed utilizing cell culture analyses. This will yield a prototype formulation for further study 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 testng of stability and sterility of these formulations, and safety and pharmacokinetic animal studies sufficient to lead to an Investigational New Drug Exemption. The completion of this work will ultimately facilitate a collaboration with a corporate partner for the licensing of our developed product.
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 I SBIR proposal involves the fabrication of therapeutic treatments for otitis media associated with tympanostomy tubes in children.