OTIVIDEX™

OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone that has completed two Phase 3 clinical trials in patients with Ménière’s disease. Otonomy announced in November 2017 that the AVERTS-2 trial, conducted in Europe, achieved its primary endpoint (p value = 0.029) and that OTIVIDEX demonstrated clinically significant treatment benefit for patients. In August 2017, the company announced negative results from the AVERTS-1 trial conducted in the United States. During the first quarter of 2018, we plan to review these results with the U.S. Food and Drug Administration (FDA) and discuss clinical requirements for registration of OTIVIDEX in patients with Ménière’s disease.