SAN DIEGO, Sept. 13, 2016 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the upcoming presentation of results from an OTIPRIO® (ciprofloxacin otic suspension) Phase 2 trial in acute otitis externa (AOE), a potential label expansion indication, as well as the company’s sponsorship of a symposium related to OTIPRIO during the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) to be held September 18-21, 2016 in San Diego.
Eric Mair, M.D., Charlotte Eye Ear Nose and Throat Associates, will present the OTIPRIO (development name OTO-201) Phase 2 trial results in AOE on Monday, September 19, in a presentation titled, “OTO-201 for the Treatment of Otitis Externa: Phase 2 Clinical Trial.” Preliminary results from this trial which enrolled a total of 75 pediatric and adult patients with unilateral AOE, also known as swimmer's ear, were announced in December 2015. This trial demonstrated the feasibility of administering OTIPRIO into the external ear canal of a patient in the physician office setting, and a clinical cure rate at both Day 8 and Day 15 of 80% or greater for patients treated with a 0.2 mL dose. These results served as the basis for a successful End-of-Phase 2 review by the U.S. Food and Drug Administration (FDA) which supported Otonomy's initiation of a single Phase 3 registration trial for OTIPRIO in patients with AOE that is expected to be completed by the end of 2016.
Otonomy Medical Affairs will be sponsoring a symposium and reception on September 20 titled, “Practice - and Payer - Perspectives on a Thermosensitive, Single-Dose, Ciprofloxacin Otic Suspension in Pediatric Patients Undergoing Tube Placement.” The symposium will review the burden of illness in pediatric patients undergoing tube placement, and discuss the clinical evidence from both registration and real-world clinical trials conducted with OTIPRIO.
“The AAO-HNSF annual meeting is the largest gathering of otolaryngologists during the year and therefore provides an excellent opportunity for continuing our efforts to establish physician awareness and advocacy to support the ongoing OTIPRIO commercial launch,” said David A. Weber, Ph.D., president and CEO of Otonomy. "We are particularly fortunate that the location of this year's meeting is in our hometown of San Diego which will facilitate our efforts to have a broad presence and high visibility to conference attendees."
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com.
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière's disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. 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, the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière's disease. 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 additional financing; Otonomy's dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311, and label expansion indications for OTIPRIO; 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, 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; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy's dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to OTIPRIO and its 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 4, 2016, 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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