Astellas Pharma, announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY 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.
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Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma
“We are pleased with the FDA’s decision to extend the use of IZERVAY 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 of GA across two pivotal studies.”
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.
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Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Post-marketing safety reporting remains consistent with that observed in the clinical trial program, with no new or significant safety signals identified, providing confidence to prescribers in IZERVAY’s safety profile.
Veeral S. Sheth, MD, MBA, FACS, FASRS, Partner and Director of Clinical Trials University Retina
“This is a welcome update for retina specialists, providing continued management options for treatment of this chronic, progressive disease that can lead to irreversible vision loss.”
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The GATHER2 study demonstrated that IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with IZERVAY versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.
IZERVAY was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization was slightly increased between IZERVAY (11.6%) versus sham (9%).
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Source – prnewswire
