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Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure
Date:6/8/2011

OTO-201, when administered at the time of tube placement, achieved a significant reduction in both middle ear bacterial load and effusion volume versus the study's control treatment. In addition, a single dose of OTO-201 demonstrated middle ear drug levels and efficacy improvements that were comparable to fourteen doses (twice daily for seven days) of CIPRODEX®* Otic, the current market leading antibiotic eardrop.

"These positive results support the advancement of OTO-201 into clinical trials for a lead indication that is commercially attractive due to the large volume of tympanostomy tube placement procedures performed each year and the lack of an FDA-approved treatment," said David A. Weber, Ph.D., president and chief executive officer of Otonomy.  "Furthermore, we believe that the sustained release dosing profile and impressive microbiological efficacy demonstrated by OTO-201 in these preclinical studies may provide the opportunity to expand the set of target indications over time to include non-surgical patients suffering from chronic otitis media."

Based on these positive study results Otonomy plans to initiate a Phase 1b clinical trial of OTO-201 by the end of 2011 in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. The company is also actively advancing OTO-104, its lead product candidate, through clinical development as a treatment for Meniere's disease. By the end of 2011, Otonomy plans to discuss its recently announced positive Phase 1b data for OTO-104 with the FDA and initiate a Phase 2 clinical trial in Meniere's disease patients.

Otitis media is defined as an infection or inflammation of the middle ear and is extremely common during childhood.  It is typically the result of a viral, bacterial or respiratory infection that spreads into the middle ear.  According to the National Institute on Deafness and Other Communication Disorders (NIDCD), three out of four child
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SOURCE Otonomy, Inc.
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