"Astellas Pharma Inc., a global life sciences company, announced the US Food and Drug Administration (FDA) approved expanded US 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, said: “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.
Since receiving a permanent J-code in April 2024, Izervay has had month-over-month growth in the US with more than 143,000 vials distributed through the end of September 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, said: “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.”
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%).
Izervay was approved by the US Food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD.
The impact of this matter on Astellas’ financial results for the fiscal year ending March 31, 2025, is expected to be minor.
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.
GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). Izervay is continuing to be evaluated in an open-label extension study.
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. The company provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health.
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