OTIC - Otonomy starts mid-stage trial of OTO-313 in tinnitus

Otonomy (OTIC) announces the initiation of a Phase 2 clinical trial of OTO-313 in patients with unilateral tinnitus, a common problem that negatively impacts millions of people by disrupting their ability to sleep, concentrate at work, and enjoy leisure activities.The randomized, double-blind, placebo-controlled Phase 2 study will enroll about 140 patients with persistent, early onset tinnitus of at least moderate severity, with top-line results expected in mid-2022.Following the successful Phase 1/2 trial, the primary efficacy endpoint will be a responder analysis based on the proportion of patients reporting a clinically meaningful improvement in TFI from baseline to both Month 1 and Month 2 following treatment.The Phase 2 trial will be conducted at about 50 clinical sites in the U.S. and Europe.

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Otonomy starts mid-stage trial of OTO-313 in tinnitus