“The success of the AVERTS-2 trial clearly demonstrates the treatment benefit of OTIVIDEX in patients with Ménière’s disease, and these results are consistent with our expectations based on the Phase 2b trial," said David A. Weber, Ph.D., president and CEO of Otonomy. “We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018.
We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing."
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