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. We 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, we announced negative results from the AVERTS-1 trial conducted in the United States. During the first quarter of 2018, we reviewed these results with the U.S. Food and Drug Administration (FDA). Based on FDA feedback, we believe that one additional pivotal trial is sufficient to support the U.S. registration of OTIVIDEX in Ménière’s disease. This trial was initiated in July 2018 with top-line results expected in the first half of 2020.