Iveric Bio has submitted the third and final part of its new drug application for Zimura to the FDA for rolling review, according to a press release.
Zimura (avacincaptad pegol), a complement C5 inhibitor under investigation for the treatment of geographic atrophy secondary to age-related macular degeneration, previously received breakthrough therapy designation.
The submission is supported by positive 12-month prespecified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials, which showed observed efficacy results for Zimura of up to 35%.
“We are excited to