AuriPro success in two Phase III trials for paediatric Middle Ear Effusion-Otonomy Inc.
Otonomy, Inc. announced positive results from two identical Phase III trials of AuriPro( OTO 201) in a combined total of 532 paediatric patients with bilateral middle ear effusion requiring Tympanostomy Tube Placement. In both trials, AuriPro achieved the primary efficacy endpoint with statistical significance (p<0.001), showed statistically significant improvements in secondary clinical endpoints and was well tolerated.>
The prospective, randomized, double-blind, sham-controlled Phase III studies enrolled subjects, ages six months to 17 years old, across approximately 60 trial sites in the United States and Canada. The primary endpoint of the 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 (drainage) or use of antibiotic rescue medication. Otonomy plans to present the full results at an appropriate medical meeting in the future.
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