Drug intelligence / Profile preview

OTO-201

Development stage
Phase 3
Lead developer
Otonomy
Modality
Small Molecules, Hydrogel Systems → Drug Delivery Systems
Administration
Otic
01

Overview

OTO-201 is a sustained-release ciprofloxacin otic suspension developed for the treatment of middle and external ear infections. It consists of ciprofloxacin, a fluoroquinolone antibiotic, formulated in a thermosensitive poloxamer 407 hydrogel that allows for single-dose administration and prolonged drug release directly to the site of infection. The primary mechanism is inhibition of bacterial DNA gyrase and topoisomerase IV, leading to bactericidal activity against susceptible pathogens. OTO-201 was developed by Otonomy for intraoperative use during tympanostomy tube placement in pediatric patients with bilateral otitis media with effusion, as well as for acute otitis externa. Clinical trials demonstrated its efficacy in reducing post-surgical otorrhea and treating acute ear infections with a favorable safety profile[1][2][3][5][7].

Brand names
Otiprio
Other names
ciprofloxacin otic suspension
02

Targets

DNA gyraseTopo IV (Bacterial Topoisomerase IV)

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