Rolling review of Zimura new drug application for geographic atrophy underway
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Iveric Bio has submitted the first part of a new drug application to the FDA for a rolling review of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration.
The first part of the NDA includes the complete clinical data package for Zimura (avacincaptad pegol).
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After the GATHER1 and GATHER2 pivotal clinical trials met their primary endpoint of statistically significantly slowing geographic atrophy progression at 12 months, Iveric requested the rolling NDA submission of the complement C5 protein inhibitor.
“We are pleased to report this important milestone and look forward to closely collaborating with the FDA throughout the review of our NDA,” Glenn P. Sblendorio, CEO of Iveric Bio, said in a press release. “As we stated previously, our special protocol assessment agreement with the FDA provides a basis for review of our NDA based on 12-month safety and efficacy results from GATHER2, taken together with the results of GATHER1.”
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