FDA approves Otiprio (ciprofloxacin otic suspension) to treat otitis media paediatric patients undergoing tympanostomy tube placement- Otonomy

Otonomy has announced that the FDA has approved Otiprio (ciprofloxacin otic suspension) for the treatment of paediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication.

Comment: 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). Placement of the tube helps to ventilate the middle ear and enables the administration of topical antibiotics to treat the infection.