Otonomy Announces Publication Supporting Development of OTO-104 as Protectant Against Cisplatin-Induced Hearing Loss

SAN DIEGO, Jan. 26, 2016 -- 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 in Audiology & Neurotology of a preclinical study titled, “The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss”. This study demonstrated that intratympanic administration of 6% OTO-104 protected against ototoxicity observed following both acute and repeat administration of the chemotherapeutic agent cisplatin.

“Our recent financing enables us to expand the scope of our development efforts, and the clinical evaluation of OTO-104 for the prevention of cisplatin-induced hearing loss is a priority based on the high unmet medical need, attractive market potential, and preclinical proof-of-concept presented in this publication,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We have completed a pre-IND review by the FDA and expect to initiate a Phase 2 feasibility trial at multiple leading oncology centers in the second half of 2016.”

“Hearing loss caused by cancer treatment with platinum-based chemotherapy agents is well documented, and the negative impact on the quality of life of cancer survivors, especially children and adolescents, is highly significant,” said Dr. David Freyer, Professor of Clinical Pediatrics and Medicine at the Keck School of Medicine, University of Southern California, and Director, Survivorship and Supportive Care Program of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital of Los Angeles. “There is great interest among pediatric oncologists, hearing specialists, and parents in having a therapeutic agent that can protect against hearing loss without concern for interfering with the effectiveness of the chemotherapy. Otic delivery of OTO-104 has this potential based on the preclinical profile in this study.”

About Cisplatin-Induced Hearing Loss

Cisplatin and other platinum-based chemotherapeutic agents are routinely used in treating numerous tumor types with approximately 500,000 patients including 2,000 children treated each year in the United States. While use of platinum agents has contributed to improved patient survival, ototoxicity and associated permanent hearing loss is well documented in the clinical literature. In particular, hearing loss has been reported in up to 90% of children and young adults treated with platinum-based agents¹. This adversely affects speech and language development and has been associated with academic and social difficulties. At this time, there is no FDA-approved drug treatment to protect against platinum-based ototoxicity.

¹Landier et al., Journal of Clinical Oncology, 2014.

About OTO-104

OTO-104 is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of various severe balance and hearing disorders. The first indication being pursued is Ménière's disease which is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Based on supportive results from a Phase 2b trial, Otonomy has initiated a Phase 3 program. The first Phase 3 trial is underway in the United States and a second trial is expected to be initiated in the EU during the first quarter of 2016. Results of both Phase 3 trials are expected in the second half of 2017. OTO-104 has been granted Fast Track designation for this indication by the FDA. Otonomy also intends to initiate clinical development for OTO-104 in a second indication, the prevention of hearing loss associated with cisplatin chemotherapy. Otonomy expects to initiate a Phase 2 feasibility clinical trial for OTO-104 in this indication in the second half of 2016.

About Otonomy

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 and commercial launch is expected in the first quarter of 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 expectations regarding the timing of commercial launch of OTIPRIO, the timing of the OTO-104 Phase 2 feasibility clinical trial for cisplatin-induced hearing loss, the timing of the OTO-104 Phase 3 clinical trial for Ménière's disease in the EU, and the timing of Phase 3 clinical trial results for OTO-104 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 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 8-K filed with the Securities and Exchange Commission (the "SEC") on January 5, 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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