Posted by Michael Wonder on 25 Feb 2017
Auris Medical receives FDA fast track designation for AM-111 in acute sensorineural hearing loss
24 February 2017 - Auris Medical today announced that the US FDA has granted fast track designation for AM-111 in the treatment of acute sensorineural (inner ear) hearing loss.
Auris Medical is currently evaluating AM-111 in two Phase 3 clinical trials. The first is the HEALOS trial, which is being conducted in several European and Asian countries. HEALOS aims to enrol approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to complete enrolment in the second quarter of 2017 and announce top-line results from this trial in the third quarter of 2017.
