Otonomy, Inc., a clinical-stage biopharmaceutical company, announced the enrollment of the first patients in a phase 2 clinical trial evaluating AuriPro for the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT).

A New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.

"Recurrent ear infections occur frequently in patients with ear tubes, and locally administered antibiotics are considered standard of care by the American Academy of Otolaryngology – Head and Neck Surgery," said David A. Weber, Ph.D., president and CEO of Otonomy. "AuriPro has potential advantages to multi-dose, multi-day ear drops by providing a full course of treatment with a single dose administered by the ENT in the office. We look forward to evaluating AuriPro in this additional indication."

The one-month, prospective, multicenter, open-label phase 2 clinical trial is expected to enroll a total of 30 patients, ages 6 months to 17 years old, in the United States. The trial is designed to characterize safety, procedural factors and clinical effect of AuriPro administered in subjects with AOMT. Clinical effect of AuriPro will be measured for up to two weeks through assessment of the presence of otorrhea, or drainage from the tube.

AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.

Otonomy submitted a New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery to the FDA on February 25, 2015. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.

Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear.