Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced the enrollment of the first patients in a phase 2 clinical trial evaluating a single administration of Otiprio (ciprofloxacin otic suspension) for the treatment of paediatric patients with acute otitis media with tympanostomy tubes (AOMT).
Otonomy previously completed a phase 2 trial that successfully demonstrated the feasibility of administering Otiprio to paediatric patients with AOMT in an office setting. This second phase 2 trial is designed to determine the most appropriate Otiprio dose for further development in this indication.
“Initiation of this phase 2 clinical trial in AOMT demonstrates our commitment to actively pursue the registration of Otiprio for expanded indications,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We believe that AOMT and acute otitis externa will more than double the US market opportunity for Otiprio if approved for these indications. Furthermore, 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.”
The one-month, prospective, multicenter, randomized, sham-controlled, blinded phase 2 clinical trial will enroll approximately 125 paediatric patients in the United States with unilateral or bilateral AOMT. The trial is designed to evaluate the safety, tolerability, and comparative clinical activity of two dose levels of Otiprio when administered as a single treatment in the physician’s office.
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).