Auris' Keyzilen misses in second Phase III tinnitus trial
Auris Medical Holding AG (NASDAQ:EARS) reported top-line data from the Phase III TACTT3 trial in about 893 patients with acute or post-acute peripheral tinnitus following traumatic cochlear injury or otitis media showing that repeated intratympanic injections of Keyzilen esketamine (AM-101) missed the primary endpoint of improving Tinnitus Functional Index (TFI) total score from baseline to day 84 vs. placebo. Secondary endpoints in the trial include patient-reported tinnitus loudness, patient-reported tinnitus annoyance, TFI sleep score, deterioration in hearing threshold and safety.
In 2016, Auris reported that Keyzilen missed the co-primary endpoints in the Phase III TACTT2 trial to treat acute peripheral tinnitus (see BioCentury, Aug. 22, 2016)...
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