Last reviewed 2026-04-23 · How we verify

OTO-201

OTO-201 is a sustained-release corticosteroid formulation designed to deliver dexamethasone directly into the middle ear to reduce inflammation and fluid accumulation.

OTO-201 is a sustained-release corticosteroid formulation designed to deliver dexamethasone directly into the middle ear to reduce inflammation and fluid accumulation. Used for Otitis media with effusion in pediatric patients.

At a glance

Mechanism of action

OTO-201 consists of dexamethasone suspended in a thermosensitive hydrogel that is injected into the middle ear space, where it provides prolonged local anti-inflammatory effects. The formulation allows for sustained drug release over weeks, reducing the need for systemic corticosteroids or repeated dosing. This localized delivery approach minimizes systemic exposure while targeting the site of inflammation in otitis media with effusion.

Approved indications

• Otitis media with effusion in pediatric patients

Common side effects

• Ear pain or discomfort
• Otorrhea (ear drainage)
• Conductive hearing loss
• Tympanic membrane perforation

Key clinical trials

• OTO-201 for the Treatment of Otitis Externa (PHASE2)
• Phase 3 Study of OTO-201 in Acute Otitis Externa (PHASE3)
• Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes (PHASE3)
• Dose Ranging Study of OTO-201 in AOMT (PHASE2)
• Open-Label Study of OTO-201 for Treatment of AOMT (PHASE2)
• Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration (PHASE3)
• OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement (PHASE3)
• OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.