Otonomy starts phase 2 trial of Otiprio in pediatric patients with AOMT

The company earlier completed a phase 2 trial that successfully demonstrated the feasibility of administering Otiprio to pediatric patients with AOMT in an office setting.

Under the second trial, the company aims to identify the most appropriate Otiprio dose for additional development in the indication.

About 125 pediatric patients will be enrolled in the one-month, prospective, multicenter, randomized, sham-controlled, blinded phase 2 clinical trial in the US.

The company will assess the safety, tolerability, and comparative clinical activity of two dose levels of Otiprio when administered as a single treatment in the physician’s office.

Otonomy president and CEO David Weber said: "We believe that AOMT and acute otitis externa will more than double the U.S. 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."

Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated to treat pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

It 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.