Otonomy (OTIC) to Present OTIPRIO Phase 2 Data in AOE at American Academy of Otolaryngology

September 13, 2016 7:36 AM EDT
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Otonomy, Inc. (Nasdaq: OTIC) announced the upcoming presentation of results from an OTIPRIO (ciprofloxacin otic suspension) Phase 2 trial in acute otitis externa (AOE), a potential label expansion indication, as well as the company’s sponsorship of a symposium related to OTIPRIO during the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) to be held September 18-21, 2016 in San Diego.

Eric Mair, M.D., Charlotte Eye Ear Nose and Throat Associates, will present the OTIPRIO (development name OTO-201) Phase 2 trial results in AOE on Monday, September 19, in a presentation titled, “OTO-201 for the Treatment of Otitis Externa: Phase 2 Clinical Trial.” Preliminary results from this trial which enrolled a total of 75 pediatric and adult patients with unilateral AOE, also known as swimmer's ear, were announced in December 2015. This trial demonstrated the feasibility of administering OTIPRIO into the external ear canal of a patient in the physician office setting, and a clinical cure rate at both Day 8 and Day 15 of 80% or greater for patients treated with a 0.2 mL dose. These results served as the basis for a successful End-of-Phase 2 review by the U.S. Food and Drug Administration (FDA) which supported Otonomy's initiation of a single Phase 3 registration trial for OTIPRIO in patients with AOE that is expected to be completed by the end of 2016.

Otonomy Medical Affairs will be sponsoring a symposium and reception on September 20 titled, “Practice - and Payer - Perspectives on a Thermosensitive, Single-Dose, Ciprofloxacin Otic Suspension in Pediatric Patients Undergoing Tube Placement.” The symposium will review the burden of illness in pediatric patients undergoing tube placement, and discuss the clinical evidence from both registration and real-world clinical trials conducted with OTIPRIO.

“The AAO-HNSF annual meeting is the largest gathering of otolaryngologists during the year and therefore provides an excellent opportunity for continuing our efforts to establish physician awareness and advocacy to support the ongoing OTIPRIO commercial launch,” said David A. Weber, Ph.D., president and CEO of Otonomy. "We are particularly fortunate that the location of this year's meeting is in our hometown of San Diego which will facilitate our efforts to have a broad presence and high visibility to conference attendees."

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