Otonomy Receives FDA Clearance For Trials Of OTO-104

OTO-104 is a proprietary formulation of the steroid dexamethasone designed to provide sustained drug release to the inner ear from a single IT injection. Preclinical studies confirm the extended release profile of OTO-104 and significant advantage over aqueous formulations which rapidly drain from the middle ear through the eustachian tube.

The study is a prospective, randomized, placebo-controlled, multicenter, Phase 1b study of OTO-104 given as a single IT injection in subjects with unilateral meniere’s disease. While the primary endpoint of the study is safety and tolerability, a number of efficacy endpoints will be monitored, including the frequency of vertigo attacks experienced by patients pre- and post-treatment.

The FDA clearance enables Otonomy to move forward with the first clinical trial of a sustained release drug delivered by direct otic injection. Using an approach called intratympanic (IT) injection, otolaryngologists deposit the drug into the middle ear via a small perforation in the tympanic membrane (eardrum). IT drug delivery results in increased drug exposure to the inner ear where the organs for balance and hearing are located, and minimizes systemic exposure that can cause side effects.

Jay Lichter, CEO and co-founder of Otonomy, said: “This marks an important milestone for the company and completes our rapid transition to a clinical-stage organization after less than eighteen months from the start of OTO-104 development. Furthermore, this advancement demonstrates the utility of our novel, patent-protected formulation approach and enables us to move other development programs toward clinical trials.”

Jeffrey Harris, chief of the Division of otolaryngology-head & neck surgery at University of California San Diego and a co-founder of Otonomy, said: “Intermittent attacks of vertigo, hearing loss, tinnitus, and aural fullness can be very disruptive and debilitating for Meniere’s disease patients. Although there are no FDA-approved drug treatments to control these symptoms, IT steroid injections appear to provide relief for many patients as demonstrated in numerous independent physician-sponsored clinical studies.”