Otonomy, Inc. announced preclinical 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 United States with the vast majority performed in children suffering from persistent otitis media (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. A number of clinical studies have demonstrated that administration of topical antibiotics during and immediately following tube placement surgery significantly reduces the risk. However, no antibiotic product has been approved by the FDA for this use and efficacy relies on caregiver compliance with multi-day dosing regimens.
OTO-201, a sustained release antibiotic designed for intra-operative administration by the ear, nose and throat (ENT) surgeon, provides a full course of treatment at the time of tube placement and eliminating the risk of compliance issues.
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. When administered at the time of tube placement, OTO-201 achieved a 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.
Based on the 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.
Release Date: June 8, 2011
Source: Otonomy, Inc.
Filed Under: Drug Discovery