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FDA issues company response letter to Astellas for IZERVAY supplemental NDA
Agency rejects proposal for positive 24-month data to be included in prescribing information; clarifies no issue with safety and benefit/risk of use.
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Astellas receives permanent J-code for IZERVAY
FDA-approved therapy is the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.Products
Two-year data reported for GATHER2 study on Izervay
Phase 3 study results indicate a continued reduction in GA lesion growth.Products
Positive 24-month data reported in phase 3 study of IZERVAY for GA
Updated safety and efficacy results follow 12-month data from the GATHER1 and GATHER2 trials.
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