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
Price :
$35
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Meniere's disease
- Focus Registrational; Therapeutic Use
- Acronyms AVERTS-2
- Sponsors Otonomy [CEASED]
- 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.