IVERIC bio's Geographic Atrophy Candidate Shows Significant Reduction In Disease Progression
- IVERIC bio Inc announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating the reduction in vision loss with ACP 2 mg versus sham treatment.
- The posthoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in the rate of vision loss with ACP 2 mg compared to sham treatment at 12 months.
- Results were consistent in the GATHER1 and GATHER2 clinical trials independently, signaling a 44% reduction and a 59% reduction, respectively, in the rate of vision loss with ACP 2 mg compared to sham over the first 12 months of treatment.
- In a combined analysis of GATHER1 and GATHER2, patients treated with ACP 2 mg experienced a 56% reduction in the rate of vision loss compared to sham over the first 12 months of treatment.
- Avacincaptad pegol (ACP) is under FDA evaluation for safety and efficacy, with a PDUFA Goal Date of August 19, 2023.
- The company plans to submit marketing authorization applications to the European Medicines Agency and the U.K. Medicines and Healthcare Regulatory Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe, which is expected in 1H of 2023.
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