Otonomy, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialisation of innovative therapeutics for diseases and disorders of the ear, announced the enrollment of the first patients in an open-label phase 3b clinical trial evaluating Otiprio (formerly known as AuriPro) in paediatric patients with a history of otitis media requiring tympanostomy tubes.
The study expands enrollment compared to the previous phase 3 studies of Otiprio to include patients undergoing common concurrent surgeries, including adenoidectomy and nasal endoscopy. Additionally, patients without bilateral middle ear effusion on the day of surgery will be included in the study. The observation period will be extended to two months post-surgery, and a questionnaire will be administered to assess caregiver burden for those patients who require treatment with antibiotic ear drops.
"This study will provide important information regarding the types of patients undergoing tympanostomy tube placement surgery that could potentially benefit from treatment with Otiprio administered as a single dose in each ear by the physician during surgery," said David A. Weber, Ph.D., president and CEO of Otonomy.
"This is also the first study to evaluate caregiver burden associated with multi-dose, multi-day antibiotic ear drops which will be assessed in a subset of study patients who require ear drop administration."
The two-month, prospective, multicenter, open-label phase 3b clinical trial is expected to enroll approximately 500 patients, ages 6 months to 17 years old, in the United States. The clinical effect of Otiprio will be measured through assessment of the presence of otorrhea, or drainage from the tube. Safety will be assessed through adverse event reporting and otoscopic examinations. Patients will receive a single administration of Otiprio in each ear during surgery.
Otiprio 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. Otiprio 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.
The US Food and Drug Administration (FDA) has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application (NDA) for Otiprio for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery. If approved within the standard review period, Otonomy anticipates a commercial launch for Otiprio in the United States in the first quarter of 2016. Otiprio is also being evaluated for two potential label expansion indications: a phase 2 feasibility trial has been completed in paediatric patients with acute otitis media with tympanostomy tubes (AOMT), and a phase 2 feasibility trial is ongoing for patients with otitis externa (swimmer's ear).