SAN DIEGO, March 18, 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 publication of the positive results of the Phase 3 clinical trials of OTIPRIO™ (ciprofloxacin otic suspension) in JAMA Otolaryngology – Head & Neck Surgery. The trial results are from two identically designed, prospective, double-blind, sham-controlled, multicenter Phase 3 randomized clinical trials of OTIPRIO in a total of 532 pediatric patients undergoing tympanostomy tube placement (TTP).
“These trials demonstrated the safety and efficacy of a single administration of OTIPRIO in pediatric patients for the treatment of bilateral middle ear effusion at the time of ear tube placement,” said Eric A. Mair, M.D., of Charlotte, Eye, Ear, Nose, & Throat Associates. “Administration of a single dose of OTIPRIO by the ENT during the procedure provides treatment with assured compliance.”
“I would like to sincerely thank the patients, their families and the physicians who participated in the OTIPRIO clinical trials,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We are extremely pleased that JAMA Otolaryngology – Head & Neck Surgery has chosen to publish these data in their journal. The commercial launch of OTIPRIO is now underway in the U.S. and the publication of these results in a well-respected, peer reviewed journal provides broad access for physicians to the Phase 3 clinical data.”
The two Phase 3 trials enrolled a total of 532 patients at approximately 50 centers in the U.S. and Canada. Pediatric patients with bilateral middle ear effusion on the day of surgery were randomized to receive TTP alone or TTP with a single intraoperative administration of OTIPRIO. The primary efficacy endpoint was treatment failure defined as the presence of otorrhea, use of otic or systemic antibiotics, loss to follow-up or missed visits through Day 15. The cumulative proportion of treatment failures was 24.6% in Trial 1 and 21.3% in Trial 2 in the OTIPRIO treatment groups, compared to 44.8% in Trial 1 and 45.5% in Trial 2 in the TTP alone groups, with p<0.001 for each trial. The most frequently reported adverse events in both trials were nasopharyngitis, irritability, and rhinorrhea. No drug-related serious adverse events were seen. No evidence of increased tube occlusion and no negative effect on results of audiometry, tympanometry, or otoscopy were noted with OTIPRIO administration.
OTIPRIO (ciprofloxacin otic suspension) 6% 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. A Phase 3 trial in Ménière's disease patients is underway in the United States with a second trial expected to be initiated 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. 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, Otonomy's plans to initiate a Phase 3 trial for OTO-104 in Ménière's disease in the EU during the first quarter of 2016. 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; 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; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 7, 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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