SAN DIEGO, March 26, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), 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 the enrollment of the first patients in a Phase 2 clinical trial evaluating AuriProTM for the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT). A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.
"Recurrent ear infections occur frequently in patients with ear tubes, and locally administered antibiotics are considered standard of care by the American Academy of Otolaryngology – Head and Neck Surgery," said David A. Weber, Ph.D., president and CEO of Otonomy. "AuriPro has potential advantages to multi-dose, multi-day ear drops by providing a full course of treatment with a single dose administered by the ENT in the office. We look forward to evaluating AuriPro in this additional indication."
The one-month, prospective, multicenter, open-label Phase 2 clinical trial is expected to enroll a total of 30 patients, ages 6 months to 17 years old, in the United States. The trial is designed to characterize safety, procedural factors and clinical effect of AuriPro administered in subjects with AOMT. Clinical effect of AuriPro will be measured for up to two weeks through assessment of the presence of otorrhea, or drainage from the tube.
AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.
Otonomy submitted a New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery to the FDA on February 25, 2015. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic injection. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and a New Drug Application for AuriPro in this indication has been submitted to the FDA. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Ménière's disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, the potential advantages of AuriPro for pediatric patients with AOMT, Otonomy's expectations regarding enrollment for the Phase 2 clinical trial evaluating AuriPro for the treatment of pediatric patients with AOMT, and Otonomy's expectations regarding the commercial launch of AuriPro in the United States. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development of product candidates, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; developments related to competitors and the industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of products; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to product candidates in the United States and throughout the world; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 18, 2015, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
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