FDA Approves Expanded Label for Astellas' Izervay, Removing Dosing Duration Limits for Geographic Atrophy
核心洞察
The FDA approved an expanded label for Astellas' Izervay, removing the limitation on dosing duration for geographic atrophy (搜索) (GA) secondary to age-related macular degeneration (搜索) (AMD).
The approval was based on positive two-year results from the GATHER2 Phase 3 clinical trial, demonstrating the efficacy and safety of Izervay with extended use.
The GATHER2 study showed that Izervay continued to reduce the rate of GA lesion growth over two years, with benefits observed as early as 6 months.
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Astellas Pharma Inc.'s IZERVAY™ (avacincaptad pegol intravitreal solution), a treatment for geographic atrophy (搜索) (GA) secondary to age-related macular degeneration (搜索) (AMD). This update removes the previous limitation on dosing duration, providing physicians and patients with greater flexibility in managing this progressive condition.
The approval is based on data from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY over two years. The study demonstrated that IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD compared to sham. The treatment benefit was observed as early as 6 months and increased over time, more than doubling over two years compared to the first year.
Clinical Trial Data
The GATHER2 trial (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trial that enrolled 448 patients with GA secondary to AMD. In the second year of the study, patients initially treated with avacincaptad pegol (ACP) in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93), while those who received sham in year 1 continued to receive sham in year 2 (n=203). The study met its primary objective at 12 months, with patients randomized to receive either ACP or a sham procedure monthly.
IZERVAY was well-tolerated over two years in the GATHER2 trial. Safety data showed one case each of non-serious intraocular inflammation and culture-positive endophthalmitis, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. The incidence of choroidal neovascularization was slightly increased between IZERVAY (11.6%) versus sham (9%) over two years.
Expert Commentary
Veeral S. Sheth, MD, MBA, FACS, FASRS, Partner and Director of Clinical Trials at University Retina, stated, "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."
Market Impact and Availability
Since receiving a permanent J-code in April 2024, IZERVAY has experienced month-over-month growth in the U.S., with over 210,000 vials distributed through the end of December 2024. Post-marketing safety reporting has remained consistent with the clinical trial program, with no new or significant safety signals identified.
About Geographic Atrophy
Age-related macular degeneration (搜索) (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. Geographic atrophy (搜索), associated with AMD, leads to further irreversible loss of vision in these 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.