Summary: Otonomy, a clinical state biopharmaceutical company focused on the development of innovative therapeutics for diseases and disorders of the ear has initiated a Phase 1 clinical trial for OTO-311, a product candidate for the treatment of tinnitus. This trial will focus on a drug that is delivered intratympanically (IT) in a single dose and is time released. The challenge of delivering medications to the inner ear is due to its protected location. In clinical trials, favorable limitation of IT injection of solution-based drug formulations is their rapid elimination from the middle ear cavity down the Eustachian tube when the patient talks, swallows or sits up. The short time that the solution remains in contact with the round window membrane in the middle ear cavity limits the amount of drug that can pass into the inner ear and also limits the duration over which drug is retained in the inner ear.
Relevance to tinnitus/hyperacusis: Because of the rapid elimination problem, currently ENTs
require patients to remain immobilized for an extended period of time following each IT injection,
and return for additional IT injections during the course of treatment. For the OTO-311 trial, Otonomy has developed a proprietary formulation technology that is designed to provide sustained drug exposure in the ear from a single IT administration. After the drug is delivered, it transforms from a liquid to a gel when exposed to body temperature, allowing the drug to remain in the ear and the patient to be able to move about the rest of their day without the need to remain immobilized. Otonomy has applied this sustained exposure technology to develop several other potential therapies for other inner ear disorders as well.
Read more about about this trial and company at Otonomy.com.