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Otonomy Doses First Subjects in Phase 3 Clinical Trials of OTO-201 in Pediatric Patients Undergoing Ear Tube Placement Surgery
Date:12/11/2013

SAN DIEGO, Dec. 11, 2013 /PRNewswire/ -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced dosing of the first patients in its two Phase 3 trials of OTO-201 for the treatment of pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. OTO-201 is Otonomy's proprietary, sustained-exposure otic formulation of the antibiotic ciprofloxacin.

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The two identical, prospective, randomized, double-blind, sham-controlled Phase 3 studies are expected to enroll a combined total of approximately 500 subjects, ages 6 months to 12 years old, across 60 trial sites in the United States and Canada. The primary endpoint of the studies is the effectiveness of OTO-201 as measured through day 15 by the cumulative proportion of study treatment failures, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. Completion of patient enrollment is expected during the second quarter of 2014.

"Following tube placement surgery, we frequently see parents of these very young patients struggle to comply with repeat administration of ear drops which is important to prevent post-operative complications," said pediatric otolaryngologist, Eric A. Mair, M.D., of Charlotte Eye, Ear, Nose & Throat Associates. "The potential to administer a full course of antibiotics with a single dose given during the procedure would be an attractive treatment option for patients, parents and physicians."

Added David A. Weber, Ph.D., president and CEO of Otonomy, "Initiating the two registration studies for O
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SOURCE Otonomy, Inc.
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