Iveric Bio submits final part of Zimura new drug application for rolling review
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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.
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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 have submitted our complete NDA for avacincaptad pegol with a request for priority review based on our breakthrough therapy designation,” Glenn P. Sblendorio, CEO of Iveric Bio, said in the release. “We continue to accelerate our launch preparations with the goal of making a treatment available as soon as possible for AMD patients impacted by GA, a disease that leads to irreversible blindness.”
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