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Otonomy Holds Investor And Analyst Day And Provides Corporate Update

The following excerpt is from the company's SEC filing.

SAN DIEGO, Oct. 7, 2015 (GLOBE NEWSWIRE) Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today held an investor and analyst day which included a review of the commercialization plans for OTIPRIO

(formerly known as AuriPro

) in patients undergoing ear tube surgery, the Phase 3 clinical trial program for OTO-104 in Ménières disease, an introduction to the OTO-311 program for tinnitus that has been cleared for Phase 1 testing, other pipeline activities as well as a general corporate update. A replay of the event webcast is available online at

in the events and presentations section under the investors tab.

Key Takeaways from the Investor and Analyst Day

Preparations for OTIPRIOs launch in the U.S. are progressing well. Otonomy expects to launch OTIPRIO in the U.S. in the first quarter of 2016 assuming FDA approval on or before the December 25, 2015 PDUFA action date.

Otonomy will pursue a paced plan for OTIPRIOs label expansion indications including the ongoing Phase 2 clinical trial in patients with acute otitis externa and initiation of a second Phase 2 trial in patients with acute otitis media and tubes (AOMT) expected in the first quarter of 2016.

Design of the OTO-104 Phase 3 clinical trials in Ménières disease has been finalized based on learnings from the Phase 2b study and discussions with the FDA held during an End-of-Phase 2 meeting. The U.S. 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. Results from both trials are expected in the second half of 2017.

FDA clearance has been received for the OTO-311 Investigational New Drug Application (IND), and initiation of a Phase 1 clinical safety trial is expected to begin before the end of 2015. 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...