Otonomy's AuriPro meets in Phase III ear disorder trials
Otonomy Inc. (San Diego, Calif.) said a single intratympanic injection of AuriPro met the primary endpoint in a pair of identical Phase III trials to treat middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery. AuriPro (formerly OTO-201) reduced the cumulative proportion of study treatment failures -- defined as the presence of ear discharge or use of antibiotic rescue medication -- through day 15 vs. sham control (p<0.001). The double-blind trials enrolled a total of 532 patients.
Otonomy plans to submit an NDA to FDA for AuriPro in the indication, but declined to provide an updated time frame. In April, the company said it planned to submit the NDA for the sustained-release gel formulation of ciprofloxacin in 1Q15. ...