Otonomy, Inc., a biopharmaceutical company, has successfully completed an end-of-phase 2 review with the US Food and Drug Administration (FDA) for Otiprio (ciprofloxacin otic suspension) in the treatment of paediatric patients with acute otitis media with tympanostomy tubes (AOMT). Based on this feedback, Otonomy plans to conduct a single, sham controlled, phase 3 trial enrolling approximately 200 paediatric patients with AOMT to support approval of Otiprio for this indication. The timing for initiation of this trial has not yet been determined.
“We are pleased with the outcome of our end-of-phase 2 communication with the FDA including their acceptance of a single phase 3 trial to support the registration of Otiprio for the treatment of AOMT,” said David A. Weber, Ph.D., president and CEO of Otonomy. “This feedback is consistent with our previous discussions regarding registration requirements for Otiprio in acute otitis externa (AOE) for which we recently submitted a supplemental New Drug Application (sNDA). We believe that, if approved for these indications, AOMT and AOE will more than double the US market opportunity for Otiprio, and that Otiprio’s single-dose, physician-administered profile is distinct from the current standard of care which requires multi-dose, multi-day administration of ear drops.”
In October 2016, Otonomy announced the successful completion of a phase 2 clinical trial that evaluated a single administration of Otiprio for the treatment of pediatric patients with AOMT. The one-month, prospective, randomized, sham-controlled, blinded phase 2 clinical trial enrolled 95 paediatric patients with unilateral or bilateral AOMT at 12 centers in the United States. The trial demonstrated that both Otiprio doses evaluated, 6 mg (0.1 mL) and 12 mg (0.2 mL), were well-tolerated and achieved higher and statistically significant (p<0.05) clinical cure rates over sham (no treatment).
According to the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement (TTP) surgery is the most common ambulatory surgery performed on children. Overall, there are approximately one million TTP procedures performed each year in the United States of which 85% are in paediatric patients, who typically have middle ear effusion and receive tubes in both ears (bilateral). The tubes are placed for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear) and can remain in place for a year or more. During this time, recurrent ear infections are common totaling approximately 900,000 cases of acute otitis media with tympanostomy tubes (AOMT) per year in the United States. Antibiotic ear drops are considered the standard of care treatment for AOMT with the typical regimen requiring several administrations each day for 7 days.
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of paediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two phase 3 trials, a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear.