Iveric bio announces FDA granted breakthrough designation for Zimura 16:04 ISEE IVERIC bio "announced that the FDA has granted Breakthrough Therapy designation for avacincaptad pegol - ACP, also known as Zimura - a novel investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to Age-Related Macular Degeneration. To date, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials." Glenn P. Sblendorio, CEO, says: "We believe this Breakthrough designation reflects the fact that both GATHER1 and GATHER2 met their primary endpoint with a safety profile that meets the stringent criteria required. We are now focused on the execution of our full NDA submission and launch preparation, with the possibility of being first to market. We look forward to working collaboratively with the FDA to expedite the review timeline for avacincaptad pegol and to potentially bringing a new therapy to AMD patients impacted by GA."
