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Otonomy Enrolls First Patient in Pivotal Phase 2b Study of OTO-104 in Meniere's Disease
Date:12/11/2013

hair of the department of otolaryngology – head and neck surgery at Medical University of South Carolina, and clinical investigator for the Phase 2b clinical trial, "Unpredictable spontaneous vertigo is life altering and a source of considerable distress for patients with Meniere's disease, and there are currently no FDA-approved drug therapies. This study may bring us closer to providing a safe and effective treatment option for the many patients with this debilitating disorder."

The study will also assess the safety and tolerability of OTO-104, which is a proprietary, sustained-exposure otic formulation of dexamethasone. Upon screening, all subjects will enter into a 4-week observational period for a baseline assessment during which subjects will record their vertigo and tinnitus symptoms via a daily diary. Following the lead-in period, eligible subjects will be randomized 1:1 to a single intratympanic injection of 12 mg OTO-104 or placebo (gel vehicle). Tinnitus will also be assessed as a secondary endpoint in the study.

Additional information about study protocol and enrollment sites for the study can be found at www.clinicaltrials.gov using the study identifier NCT01412177.

About OTO-104
OTO-104 is a sustained-exposure formulation of the steroid dexamethasone that has been designed for intratympanic (IT) injection into the middle ear for the potential treatment of a broad range of inner ear disorders including vertigo and acute onset hearing loss. OTO-104 is based on Otonomy's proprietary formulation technology which is intended to overcome the limitations associated with the use of unapproved short-acting solutions in the ear. These include limited and variable drug exposure, need for repeat IT injections, and potential for suboptimal efficacy. OTO-104 successfully completed a Phase 1b trial in Meniere's disease patients that demonstrated a clinically meaningful reduction in vertigo f
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