Otonomy announces top-line results for the phase III clinical trial of Otividex in patients with Ménière's disease.

Otonomy, Inc., has announced that the Phase III clinical trial of Otividex (OTO 104) in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for Otividex vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP). David A. Weber, Ph.D., president and CEO of Otonomy said "Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a large patient population with significant unmet need and no approved drug therapy. These programs provide an attractive opportunity for the company with clinical readouts anticipated in mid-2022.