SAN DIEGO, Dec. 1, 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 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.
OTIPRIOTM is a physician administered, single dose formulation of ciprofloxacin in development for various indications that are currently treated with multi-dose, multi-day antibiotic ear drops. 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 tympanostomy tube placement (TTP) surgery. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases although they are not FDA-approved for this indication. If OTIPRIO is approved on or before its PDUFA date, Otonomy anticipates a commercial launch in the United States in the first quarter of 2016. OTIPRIO is also in development for two potential label expansion indications: a Phase 2 feasibility trial has been completed and a second Phase 2 trial is being planned for the first quarter of 2016 in pediatric patients with acute otitis media with tympanostomy tubes (AOMT), and a Phase 2 feasibility trial in patients with acute otitis externa (swimmer's ear) has recently been completed.
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 the company's New Drug Application. OTO-104 is a steroid in development for the treatment of Ménière's disease and other balance and hearing disorders. A Phase 3 trial in Ménière's disease patients has been initiated in the United States with a second trial expected to begin in the EU during the first quarter of 2016. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. 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 of the FDA meeting regarding OTIPRIO for otitis externa, the timing of its second Phase 2 clinical trial for OTIPRIO for the treatment of acute otitis media with tympanostomy tubes (AOMT), and the timing regarding the Phase 3 clinical trials for OTO-104. 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 November 10, 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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