SAN DIEGO, June 8, 2011 /PRNewswire/ -- Otonomy, Inc., a developer of innovative therapeutics for diseases and disorders of the ear, today announced positive results for OTO-201, a sustained release gel formulation of the antibiotic ciprofloxacin, in multiple preclinical studies evaluating the treatment of middle ear effusion (fluid) at the time of tympanostomy tube placement surgery. Approximately one million tube placement procedures are conducted each year in the U.S. with the vast majority performed in children suffering from recurrent or persistent otitis media (inflammation or infection of the middle ear). A significant portion of patients receiving tubes have middle ear effusion at the time of surgery which significantly increases their risk of post-operative complications including otorrhea (drainage) and tube occlusion. A number of clinical studies have demonstrated that administration of topical antibiotics during and immediately following tube placement surgery significantly reduces this risk. However, no antibiotic product has been approved by the United States Food and Drug Administration (FDA) for this use and efficacy relies on caregiver compliance with multi-day dosing regimens. OTO-201 is a sustained release antibiotic designed for intra-operative administration by the ear, nose and throat (ENT) surgeon, thereby providing a full course of treatment at the time of tube placement and eliminating the risk of compliance issues.
Preclinical study results demonstrating sustained middle ear drug exposure and efficacy of OTO-201 were presented yesterday at the 10th International Symposium on Recent Advances on Otitis Media. Data demonstrated that a single administration of OTO-201 delivered ciprofloxacin concentrations to the middle ear that were sustained for more than one week above the minimum inhibitory concentration (MIC) required for eradication of common otitis media pathogens. Findings in an otitis media model confirmed that