Trial Profile

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 30 Jun 2023

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At a glance

01 Jul 2023 Results assessing the efficacy of intratympanic OTO-104 for the treatment of Meniere's disease from NCT02717442, NCT02612337, NCT03664674 studies, published in the Otology and Neurotology.
02 Oct 2020 According to an Otonomy media release, based on the positive results from this and 104-201811 trial the company expect to submit a New Drug Application for OTIVIDEX in the third quarter of 2021.
04 Aug 2020 According to an Otonomy media release, the Negative Binomial model provides the best fit of the OTIVIDEX clinical data based on this and AVERTS-2 trial and integrated dataset from both trials.

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