Otonomy Presents AuriPro Phase 3 Results at American Society of Pediatric Otolaryngology Conference

Otonomy, Inc.

, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that results from two identical Phase 3 trials of AuriPro™ were presented at the annual American Society of Pediatric Otolaryngology (ASPO) meeting, held during the Combined Otolaryngology Spring Meetings in Boston. This data supports Otonomy's New Drug Application (NDA) that has been submitted to the U.S. Food and Drug Administration (FDA) for the approval of AuriPro as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. Results of these prospective, randomized, double-blind, sham-controlled Phase 3 trials demonstrated that AuriPro achieved the primary efficacy endpoint, reduction in the incidence of treatment failures, with statistical significance (p<0.001) and that AuriPro was well tolerated. In these trials, AuriPro reduced the risk of treatment failure, as measured by the occurrence of post-operative otorrhea (drainage) or any use of rescue antibiotics, by an average of 49 percent in all randomized patients across the two trials, and the rate of post-operative otorrhea or use of rescue antibiotics for documented otorrhea or otitis media by an average of 62 percent in all randomized patients across the two trials (p≤ 0.004), in each case as compared to sham. The studies enrolled a combined total of 532 pediatric patients. "These two AuriPro Phase 3 trials are the first large-scale, multi-center studies demonstrating the clinical importance of antibiotic administration to reduce the occurrence of post-operative complications such as otorrhea following ear tube placement surgery," said Eric Mair, M.D., of Charlotte Eye Ear Nose & Throat Associates. "These results also demonstrate that a single dose of AuriPro, administered by the ENT during the procedure, provides a full course of treatment and avoids the risk of compliance problems inherent to multi-dose, multi-day, off-label antibiotic ear drops given by the parent or caregiver." The presentation titled "Results Of Two Phase 3 Clinical Trials To Assess The Safety And Efficacy Of Extended-Release Ciprofloxacin Gel For Intratympanic Administration In Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement" was delivered by Dr. Mair.