Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies.

ABSTRACT:

Objective

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

Study designs

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

Setting

The United States and throughout Europe.

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.

Main outcome measures

The primary efficacy endpoint was measured by the number of definitiv

SUBMITTER: Phillips J 

PROVIDER: S-EPMC10289225 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature