Objective

To determine the efficacy of intratympanic OTO-104 for the treatment of Ménière's disease.

Three randomized, double-blind, placebo-controlled, multicenter studies of OTO-104 in patients with Ménière's disease.

Patients

Individuals with Ménière's disease aged 18 to 85 years.

Interventions

All three studies were conducted according to a similar protocol, whereby after a 1-month lead-in period, eligible patients received a single intratympanic injection of either 12 mg OTO-104 (otic formulation of dexamethasone in thermosensitive poloxamer) or placebo (1:1) and were observed for 3 months.