FDA Expands Label for Astellas' IZERVAY for Geographic Atrophy

Astellas Pharma Inc., a prominent player in the pharmaceutical industry, has recently received approval from the U.S. Food and Drug Administration (FDA) for an expansion of the prescribing information for IZERVAY™ (avacincaptad pegol intravitreal solution). This development allows for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without restrictions on the duration of dosing. The approval grants healthcare providers and patients enhanced flexibility in managing this condition.

The FDA's decision followed Astellas' resubmission of the supplemental New Drug Application (sNDA) for IZERVAY in late 2024. This resubmission came shortly after discussions with the FDA, which provided clarity on earlier feedback from a Complete Response Letter issued in November 2024.

Marci English, Senior Vice President of Biopharma and Ophthalmology Development at Astellas, expressed satisfaction with the FDA's approval. She emphasized that IZERVAY has been a reliable option for GA patients since its 2023 launch, being the only FDA-approved treatment that has consistently shown a significant reduction in GA progression through two critical studies.

The label update for IZERVAY is supported by positive outcomes from the GATHER2 Phase 3 clinical trial, which assessed the drug's effectiveness and safety over a two-year period. Since receiving a permanent J-code in April 2024, IZERVAY's distribution in the U.S. has seen consistent growth, with over 143,000 vials distributed by the end of September 2024. Post-marketing safety data aligns with the clinical trial results, revealing no new or significant safety concerns, which reassures prescribers of the drug's safety profile.

Dr. Veeral S. Sheth, a specialist in retina diseases, highlighted the importance of this update for retina specialists, as it offers more options for managing the chronic and progressive nature of GA, which can ultimately lead to irreversible vision loss.

The GATHER2 study demonstrated that IZERVAY effectively slowed the growth of GA lesions in patients with GA secondary to AMD over two years compared to placebo. The benefits of IZERVAY were noticeable as early as six months into the trial and continued to increase over time, more than doubling by the end of the second year compared to the first year.

Throughout the GATHER2 trial, IZERVAY was well-tolerated, with only minor cases of non-serious intraocular inflammation and culture-positive endophthalmitis reported. There were no instances of ischemic neuropathy or severe intraocular inflammation, such as retinal vasculitis. However, a slight increase in choroidal neovascularization incidence was observed in the IZERVAY group (11.6%) compared to the sham group (9%).

The FDA initially approved IZERVAY on August 4, 2023, for treating GA secondary to AMD. Astellas anticipates that the financial impact of this expansion on its results for the fiscal year ending March 31, 2025, will be minimal.

IZERVAY is a prescription eye injection specifically designed to treat GA, the advanced stage of dry AMD. Patients should avoid receiving IZERVAY if they have an existing eye infection or active swelling in or around the eye. Serious side effects may include eye infection or retinal detachment, and there is a risk of developing wet AMD. Patients should report any visual disturbances to their healthcare provider.

The most common side effects of IZERVAY include bleeding in the white part of the eye, increased eye pressure, blurred vision, and the development of wet AMD. Patients are advised to inform their healthcare provider of any bothersome side effects and are encouraged to report negative side effects to the FDA.

Geographic atrophy, related to AMD, is a leading cause of central vision loss in older adults, resulting from the degeneration of retinal cells and underlying blood vessels in the macula. The GATHER2 clinical trial was a significant study evaluating the safety and efficacy of IZERVAY in patients with GA secondary to AMD, demonstrating the drug's potential in addressing this unmet medical need.