Otonomy submits NDA for AuriPro

Otonomy Inc. (NASDAQ:OTIC) submitted an NDA to FDA for AuriPro, a sustained-release gel formulation of ciprofloxacin, to treat middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.

Otonomy based its submission on results of two Phase III trials, in which a single intratympanic injection of AuriPro met the primary endpoint of reducing the cumulative proportion of study treatment failures (p<0.001) (see BioCentury Extra, July 8, 2014). ...