Shares of biopharmaceutical company IVERIC bio (NASDAQ:ISEE) are surging in the pre-market session today after the U.S. Food and Drug Administration granted a breakthrough therapy designation for its investigational complement C5 inhibitor avacincaptad pegol (ACP) for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD).
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Importantly, ACP is the only therapy to bag the designation for geographic atrophy. Further, the designation was based on 12-month primary endpoint data and enables accelerated development and regulatory review of the therapy.
The company is now focusing on a full NDA submission and market launch activities. Geographic atrophy is an advanced stage of AMD and causes an irreversible loss of vision.
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