Research
Real-world data support IZERVAY's long-term benefits
OLE trial of the GATHER2 study finds continued GA lesion growth for up to 3.5 years—with earlier intervention offering greater protection of the retinal tissue.Products
FDA approves updated label for IZERVAY to treat GA
Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.Products
FDA accepts revised sNDA of IZERVAY for GA
Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.Products
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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