OTIC - Otonomy completes enrollment in pivotal study of Otvidex in inner ear disorder

Otonomy (OTIC) has completed the enrollment of 142 subjects in a Phase 3 clinical trial evaluating Otividex, a sustained-exposure formulation of the corticosteroid dexamethasone injected through the eardrum, in patients with Ménière’s disease, a disorder of the inner ear that can lead to vertigo and hearing loss.The primary endpoint is the number of vertigo days in three months compared to placebo.The company says it remains on track to file a U.S. marketing application in Q3 2021.An earlier Phase 3, AVERTS-1, failed to beat placebo which prompted OTIC to terminate a second Phase 3, AVERTS-2.

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Otonomy completes enrollment in pivotal study of Otvidex in inner ear disorder