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Major FDA Victory: IZERVAY's Unlimited Duration Now Approved for Macular Degeneration Treatment

Summary by stocktitan.net
FDA removes time restrictions on IZERVAY for geographic atrophy treatment, backed by strong Phase 3 data showing doubled benefits over two years.
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Managed Healthcare ExecutiveManaged Healthcare Executive

FDA Approves Expanded Label for Izervay, No Dosing Duration Limit

The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic atrophy secondary to age-related macular degeneration.

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Eyewire+Eyewire+

FDA Expands Label for Izervay for GA Allowing for No Limitation on Duration of Dosing

The FDA has approved an expanded label for Astellas Pharma's geographic atrophy drug Izervay (avacincaptad pegol intravitreal solution), allowing the drug to be used without a limitation on duration of dosing.  The approval, which provides physicians and patients greater flexibility when managing GA, follows Astellas’ resubmission of the supplemental new drug application (NDA) for Izervay on December 26, 2024, within days of meeting with the FDA…

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optometrytimes.comoptometrytimes.com

FDA approves amended label for Izervay for geographic atrophy

The approval follows a refiling after the FDA issued a Complete Response Letter due to language on the amended label.

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PharmaphorumPharmaphorum

FDA changes its mind on Astellas' geographic atrophy drug

Astellas has shored up the competitive profile of Izervay for eye disorder geographic atrophy, getting FDA approval for extended treatment.

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stocktitan.netstocktitan.net

Major FDA Victory: IZERVAY's Unlimited Duration Now Approved for Macular Degeneration Treatment

FDA removes time restrictions on IZERVAY for geographic atrophy treatment, backed by strong Phase 3 data showing doubled benefits over two years.

Read Full Article
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stocktitan.net broke the news in on Wednesday, February 12, 2025.
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