Astellas Pharma : FDA Approves Expanded Label For IZERVAY For Geographic Atrophy

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration approved expanded U.S. Prescribing information for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, IZERVAY is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA.

The approved label update was based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY through year 2.

IZERVAY was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy secondary to age-related macular degeneration.

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