SAN DIEGO, May 12, 2017 (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 3b clinical trial conducted in a broad pediatric population undergoing tympanostomy tube placement (TTP) surgery, the presentation of results from an OTIPRIO Phase 2 trial in pediatric patients with acute otitis media with tympanostomy tubes (AOMT), and the company’s sponsorship of a symposium relating to reimbursement. These events will take place during the 2017 American Society of Pediatric Otolaryngology (ASPO) Annual Meeting to be held May 18-21, 2017 in Austin, Tex.
Joseph Dohar, M.D., Professor, Department of Pediatric Otolaryngology at the University of Pittsburgh School of Medicine will present the OTIPRIO Phase 3b trial results on Friday, May 19, in a presentation titled, “Post-Tympanostomy Tube Otorrhea Rates in the Real-World Practice Setting: Data from OTO-201 Phase 3b Clinical Trial.” As previously announced, this trial demonstrated that OTIPRIO was effective in reducing post-operative otorrhea in a broader pediatric patient population at a rate consistent with the Phase 3 trials, and that the incidence of otorrhea was similar for patients covered by commercial insurance and Medicaid over the eight-week follow-up period.
John Ansley, M.D., Carolina Ear, Nose & Throat Clinic, will present the OTIPRIO Phase 2 trial results for pediatric patients with AOMT on Friday, May 19, in a presentation titled, “OTO-201 Single Administration for the Treatment of Acute Otitis Media with Tympanostomy Tubes in Pediatric Subjects: Phase 2 Study.” Also previously announced, this study demonstrated that both OTIPRIO doses evaluated were well-tolerated and achieved higher and statistically significant (p<0.05) clinical cure rates over sham (no treatment).
In addition, Otonomy will be sponsoring a symposium on Saturday, May 20, titled, “Navigating Reimbursement with Otonomy Answers™”. This symposium will provide an overview of the reimbursement coding systems used by hospital outpatient departments, describe the various drug payment systems used by payors, and discuss the reimbursement resources available for supporting patient access to OTIPRIO.
“Our scientific and medical presence at ASPO 2017 reflects our ongoing commitment to support the clinical utility of OTIPRIO and advance the pediatric otolaryngology field through generation of patient outcomes data,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Given the complexity of reimbursement, especially in a hospital setting, we are also pleased to offer a symposium on this topic for attendees which will include a review of the resources available through Otonomy and our Otonomy Answers program.”
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, an sNDA has been submitted to the FDA for acute otitis externa (AOE) and a successful Phase 2 trial has been completed in patients with acute otitis media with tympanostomy tubes (AOMT). OTIVIDEX™ (formerly OTO-104) is a steroid in development for the treatment of Ménière's disease and other balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are ongoing, AVERTS-1 in the United States and AVERTS-2 in Europe, with AVERTS-1 results expected in the third quarter of 2017 and AVERTS-2 results expected by the end of 2017. In addition, a Phase 2 trial of OTIVIDEX is underway in patients at risk for cisplatin-induced hearing loss. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial with a Phase 2 trial expected to be initiated in the second half of 2017. A fourth program targeting sensorineural hearing loss including age-related hearing loss is in preclinical development. 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, the timing of Phase 3 results for OTIVIDEX and the timing of a Phase 2 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 additional financing; Otonomy's dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTIVIDEX 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 nonclinical 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 nonclinical 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 Annual Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 4, 2017, 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.
Heidi Chokeir, Ph.D.
Senior Vice President
Westwicke PartnersRobert H. Uhl