Otonomy announced positive results from two Phase 3 trials of AuriPro (ciprofloxacin) for intra-operative treatment of middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.
The two prospective, randomized, double-blind, sham-controlled trials evaluated 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. The primary endpoint for both studies was the effectiveness of AuriPro as measured by the cumulative proportion of study treatment failures through day 15, which is defined as the presence of otorrhea or use of antibiotic rescue medication. The primary efficacy endpoint for both trials was met with statistical significance (P<0.001).
AuriPro is a proprietary, sustained-exposure formulation of the antibiotic ciprofloxacin designed to treat a broad range of otic conditions, including recurrent and persistent otitis media.
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