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, and we expect to initiate this trial in mid-2018.