FDA Extends Approval for Izervay
Astellas Pharma Inc. announced the (FDA 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 approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for Izervay on December 26, 2024, within days of meeting with the FDA to clarify the Agency's feedback provided in the Complete Response Letter (CRL) issued in November 2024.
Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma; "We are pleased with the FDA's decision to extend the use of Izeervay for longer-term administration—further solidifying IZERVAY's status as a trusted choice for thousands of GA patients since its launch in 2023. To date, Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing Izervay through year 2.
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