Iveric Bio Stock Jumps Higher On SPA Agreement From FDA For Zimura Study In Geographic Atrophy

Iveric Bio Inc ISEE has received written agreement from the FDA under a Special Protocol Assessment (SPA) for the overall design of the GATHER2 trial of Zimura (avacincaptad pegol) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
As previously announced, the Company expects to complete enrollment in GATHER2 in late July.
Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022
In connection with the SPA, the Company will modify the primary efficacy endpoint for the GATHER2 trial from the mean rate of change in GA area over 12 months measured by fundus autofluorescence (FAF) at three time points: baseline, month six and month 12, to the mean rate of growth (slope) estimated based on GA area measured by FAF in at least three time points: baseline, month six and month 12.
The FDA also indicated that as part of future application submission for Zimura, the GATHER1 results would be considered using the original prespecified primary efficacy endpoint analysis, together with a posthoc analysis using the same FDA preferred method that will be used for the GATHER2 trial.
Price Action: ISEE shares are up 19% at $9.45 during the premarket session on the last check Tuesday.