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  • December 14, 2016
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ZUG, Switzerland, June 14, 2016 (GLOBE NEWSWIRE) — Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, is hosting an event focused on the treatment of acute inner ear tinnitus and the AM-101 Phase 3 clinical development program. (Nasdaq:OTIC), a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced topline results from its Phase 2b trial evaluating OTO-104 in patients with unilateral Ménière’s disease. In two recently completed Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. Last month the company began enrollment in its Phase III trial for KeyzilenTM (AM-101) in acute and post-acute inner ear tinnitus. 43% for placebo with a p value of 0.067, which narrowly missed achieving statistical significance. The change in the Tinnitus Functional Index, which measures tinnitus burden, is a secondary efficacy outcome. The first trial, HEALOS, which is being conducted in several European and Asian countries, was initiated in November 2015 and is enrolling approximately 255 patients.

Something else must also happen, and there are a variety of factors that must combine with hearing impairment, such as a deficiency in BDNF or some type of recent emotional trauma. The company plans to enroll over 300 patients suffering from severe to profound forms of ISSNHL. Otonomy’s third candidate, the preclinical tinnitus treatment OTO-311, is in line to enter the clinic next year, the company said. About Acute Inner Ear Tinnitus Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Phase 3 trial is expected to begin in the fourth quarter of 2015 with the EU Phase 3 trial to start in the first quarter of 2016. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 53772865. Surgery (breast and sentinel node or axillary lymph node resection) was complete three to seven weeks after the last dose of investigational product in the neoadjuvant phase, and pCR was analyzed.

OTO-311 is a single-dose treatment in development for tinnitus. • Through corporate development activities, the company has secured rights to multiple potential product candidates for a fourth program targeting sensorineural hearing loss, the largest market opportunity within the otology field, and evaluations are ongoing regarding ex-U.S. partnering opportunities for Otonomy’s current products. Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Tinnitus may be transitory; however, it may also become permanent. Malignant Reed Sternberg cells invade and destroy the architecture of the lymph nodes and infiltrate major organs such as the liver and spleen. 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 FDAhas assigned a PDUFA action date of December 25, 2015 for Otonomy’s New Drug Application.

OTO-104 is a steroid that has completed a Phase 2b clinical trial in 154 patients with Ménière’s disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière’s disease patients with at least one trial initiated by the end of 2015. It is administered intratympanically in one single dose. A Phase 1 clinical safety trial for OTO-311 is expected to begin before the end of 2015. For additional information please visit To participate in this conference call, dial 1-877-280-3459 (USA) or +1-646-254-3387 (International), and enter passcode 9451099. 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 its Phase 2 clinical trials for OTIPRIO for the treatment of acute otitis media with tympanostomy tubes (AOMT) and otitis externa, the timing, duration, design and expectations regarding the two Phase 3 clinical trials for OTO-104, the timing of the initiation of the Phase 2 clinical trials for OTO-311, the market for sensorineural hearing loss, and Otonomy’s estimated cash position through 2017. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. 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 12, 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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