Otonomy Completes Enrollment in OTIPRIO(TM) Phase 2 Trial and Demonstrates Clinical Feasibility in Patients With Acute Otitis Externa

Otonomy, Inc.

, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced it has completed enrollment in a Phase 2 trial of OTIPRIOTM in patients with acute otitis externa, also known as swimmer's ear, and that preliminary results demonstrate clinical feasibility of OTIPRIO for this label expansion indication. The one-month, prospective, multicenter, open label Phase 2 clinical trial enrolled a total of 75 pediatric and adult patients with unilateral acute otitis externa. Patients were randomized to receive a single administration of OTIPRIO at one of three dose volumes: 0.1 mL, 0.2 mL and 0.4 mL. Results of this trial demonstrate the feasibility of administering OTIPRIO, a thermosensitive gel containing ciprofloxacin, into the external ear canal of awake patients by a physician in the office setting. In addition, preliminary results demonstrate that a single administration of OTIPRIO provided clinical cure at Day 15 in the majority of patients with a greater than 80 percent rate of clinical cure for patients treated with the 0.2 mL (12 mg) dose, which is the preferred dose for further development. Final results of the trial will be presented at an upcoming medical conference. "We are very encouraged by the preliminary results of this trial which support the feasibility of treating otitis externa patients with a single administration of OTIPRIO in the physician's office," said David A. Weber, Ph.D., president and CEO of Otonomy. "Furthermore, we believe that these results support the initiation of a registration program for OTIPRIO in this label expansion indication and we intend to discuss the requirements for such a program with the FDA following our upcoming PDUFA date for OTIPRIO's lead indication." The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 25, 2015 for Otonomy's New Drug Application (NDA) for OTIPRIO as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement surgery.