- The FDA has granted Breakthrough Therapy designation to IVERIC bio Inc's ISEE avacincaptad pegol (ACP, also known as Zimura), a novel investigational complement C5 inhibitor for geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
- 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.
- Related: IVERIC bio Stock Soars After Encouraging Geographic Atrophy Trial Data.
- Recently, Iveric Bio announced the submission of the first part of its New Drug Application (NDA) for rolling review, which included the full clinical data package from the GATHER1 and GATHER2 pivotal trials. The company is on track to complete the final part of the NDA submission by the end of this year.
- "In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month six that was persistent and continued to increase over time, with observed efficacy rates of up to 35%," said Pravin U. Dugel, MD, President of Iveric Bio.
- Price Action: ISEE shares are 20.1% higher at $20.70 during premarket trading on the last check Friday.
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