SAN DIEGO, Nov. 3, 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 ear, today announced the enrollment of the first patients in an open-label Phase 3b clinical trial evaluating OTIPRIO™ (formerly known as AuriPro™) in pediatric patients with a history of otitis media requiring tympanostomy tubes.
The study expands enrollment compared to the previous Phase 3 studies of OTIPRIO to include patients undergoing common concurrent surgeries, including adenoidectomy and nasal endoscopy. Additionally, patients without bilateral middle ear effusion on the day of surgery will be included in the study. The observation period will be extended to two months post-surgery, and a questionnaire will be administered to assess caregiver burden for those patients who require treatment with antibiotic ear drops.
"This study will provide important information regarding the types of patients undergoing tympanostomy tube placement surgery that could potentially benefit from treatment with OTIPRIO administered as a single dose in each ear by the physician during surgery," said David A. Weber, Ph.D., president and CEO of Otonomy. "This is also the first study to evaluate caregiver burden associated with multi-dose, multi-day antibiotic ear drops which will be assessed in a subset of study patients who require ear drop administration."
The two-month, prospective, multicenter, open-label Phase 3b clinical trial is expected to enroll approximately 500 patients, ages 6 months to 17 years old, in the United States. The clinical effect of OTIPRIO will be measured through assessment of the presence of otorrhea, or drainage from the tube. Safety will be assessed through adverse event reporting and otoscopic examinations. Patients will receive a single administration of OTIPRIO in each ear during surgery.
OTIPRIOTM 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. OTIPRIO 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.
The U.S. Food and Drug Administration (FDA) has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application (NDA) for OTIPRIO for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery. If approved within the standard review period, Otonomy anticipates a commercial launch for OTIPRIO in the United States in the first quarter of 2016. OTIPRIO is also being evaluated for two potential label expansion indications: a Phase 2 feasibility trial has been completed in pediatric patients with acute otitis media with tympanostomy tubes (AOMT), and a Phase 2 feasibility trial is ongoing for patients with otitis externa (swimmer's ear).
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 ear following a single administration. Otonomy has three product candidates in development. OTIPRIO™ 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 the FDA has assigned a PDUFA action date of December 25, 2015 for Otonomy's New Drug Application. OTO-104 is a steroid that has completed a Phase 2b clinical trial in 154 patients with Ménière's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière's disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. A Phase 1 clinical safety trial for OTO-311 is expected to begin before the end of 2015. 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 future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, Otonomy's expectations regarding the timing of commercial launch, the timing regarding the Phase 3 clinical trials for OTO-104, and the timing of the initiation of the Phase 1 clinical trial for OTO-311. 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain substantial additional financing; Otonomy's dependence on the regulatory and commercial success of OTIPRIO and OTO-104 and advancing additional product candidates, such as OTO-311; 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; competition in the biopharmaceutical 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; expectations regarding potential market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 12, 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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