Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that it has successfully completed an End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) for OTIPRIO™ (ciprofloxacin otic suspension) in the treatment of acute otitis externa, also known as swimmer’s ear. Based on this review, the company intends to initiate a single Phase 3 clinical trial for OTIPRIO in patients with acute otitis externa during the second quarter of 2016 and expects to complete this trial and report topline results in the fourth quarter of 2016. If the results are positive then Otonomy expects to submit a supplemental New Drug Application (sNDA) to the FDA in the first half of 2017.
In December 2015, Otonomy announced the completion of a one-month, prospective, multicenter, open label Phase 2 clinical trial that enrolled a total of 75 pediatric and adult patients with acute otitis externa. 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 which is the dose that will be evaluated in the Phase 3 clinical trial.
The one-month, prospective, randomized, double-blinded, sham-controlled, multicenter, Phase 3 clinical trial is expected to enroll approximately 500 patients age 6 months and older with acute otitis externa, in the United States. Subjects will be randomized to receive a single administration of 12 mg OTIPRIO (equal to 0.2 mL) or sham (empty syringe) to the external ear canal of the affected ear(s). The primary endpoint is clinical cure at Day 8 where clinical cure is defined as complete resolution of the signs and symptoms related to acute otitis externa (i.e. tenderness, erythema, and edema) as determined by a blinded clinical assessor. Safety outcome measures will include reporting of adverse events and otoscopic examinations.
