Iveric bio received a special protocol assessment from the FDA for GATHER2, a pivotal clinical trial investigating Zimura in patients with geographic atrophy secondary to age-related macular degeneration, according to a press release.
The FDA recommended a modified primary efficacy endpoint for the phase 3 trial of Zimura (avacincaptad pegol), which Iveric accepted. The modification was “from the mean rate of change in GA area over 12 months measured by fundus autofluorescence (FAF) at three timepoints: baseline, month 6 and month 12, to the mean rate of growth (slope) estimated (Read more...)