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Otonomy Presents Positive New Findings From Phase 1b Study of OTO-104 in Meniere's Disease at International Conference
Date:9/29/2011

SAN DIEGO, Calif., Sept. 29, 2011 /PRNewswire/ -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.  The presented data showed that patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus as compared to placebo.  These results were presented today in an oral presentation at the 28th Politzer Society Meeting in Athens, Greece.

Researchers presented findings showing clinically meaningful reductions in vertigo frequency at three months with the 12 mg OTO-104 dose as compared to placebo.  Prior to treatment, patients in both the 12 mg OTO-104 and placebo groups experienced an average of eight days with definitive vertigo episodes during a baseline period of one month. Following a single intratympanic (IT) injection, patients in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, at three months following treatment, the 12 mg study group experienced a 70 percent greater reduction from baseline in the number of days with definitive vertigo episodes.  There was no clinically meaningful difference in vertigo frequency between the 3 mg OTO-104 and placebo groups at three months following treatment.

Additionally, the presented study data demonstrated that both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus as measured by the Tinnitus Handicap Inventory (THI-25). THI is a clinically validated patient-reported measure that can be used to quantify th
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