Otonomy, Inc. announced an update on its corporate activities and product pipeline. NDA Submission for AuriPro planned for the first quarter of 2015: Preparation of the New Drug Application (NDA) for AuriPro is in process, and incorporates feedback received from a Pre-NDA meeting and communications with the FDA. The company expects to submit the NDA to the FDA during the first quarter of 2015.

If approved within the 12 month standard review period, the company anticipates product introduction in the United States during the first half of 2016. The findings from two identical Phase 3 trials of AuriPro with a combined total of 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement (TTP) surgery will form the basis of the NDA submission. In both trials, AuriPro achieved the primary efficacy endpoint of reducing the rate of treatment failures with statistical significance (p<0.001) and was well tolerated.

Results have been accepted for presentation at the American Society of Pediatric Otolaryngology (ASPO) spring meeting in April 2015. Phase 2b results for OTO-104 in M ni re's disease patients expected in second quarter of 2015: the company completed enrollment in its Phase 2b clinical trial in December 2014, exceeding the target enrollment of 140 patients with a final total of 154 patients. This trial is expected to serve as one of two pivotal, single-dose efficacy trials required to support U.S. regulatory approval.

The company plans to report results from this clinical trial during the second quarter of 2015, and if results are positive, initiate a second pivotal trial of OTO-104 in 2015. A multiple-dose safety study with OTO-104 in patients with M ni re's disease was initiated in the United Kingdom in October 2014 and is on-going. OTO-104 for M ni re's disease has been granted Fast Track designation by the FDA.

Initiation of a clinical trial for AuriPro in one or more additional indications expected to begin in first half of 2015: Potential expansion indications for AuriPro include recurrent ear infections in patients with tympanostomy tubes, acute otitis externa, chronic suppurative otitis media (a perforated tympanic membrane with persistent drainage from the middle ear), and prophylaxis following middle ear surgeries. Otonomy plans to initiate clinical trials for AuriPro in one or more of these indications during the first half of 2015.