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Astellas has been green-lighted for long-term use against the late-stage form of dry AMD.
On February 13, 2025, the U.S. Food and Drug Administration (FDA) approved an expanded label for Izervay™ (avacincaptad pegol intravitreal solution; Astellas Pharma, Tokyo, Japan), removing limitations on the duration of dosing for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“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,” said Marci English, senior vice president of Biopharma and Ophthalmology Development at Astellas, in a news release.
“To date, Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies.”
The approval follows Astellas’ resubmission of a supplemental New Drug Application (sNDA) on December 6, 2024, after addressing feedback from the FDA’s Complete Response Letter (CRL) issued in November 2024.
Clinical data and safety profile
The updated label is based on data from the GATHER2 phase III clinical trial, which showed Izervay’s sustained efficacy in slowing GA progression through two years.1
“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,” said Dr. Veeral S. Sheth, partner and director of Clinical Trials at University Retina (USA).
GATHER2 data demonstrated that Izervay reduced GA lesion growth as early as six months, with benefits increasing over time through two years.1
[Tenghui Chen shares key takeaways from the GATHER2 study.]
The incidence of choroidal neovascularization was slightly higher with Izervay (11.6%) compared to sham (9%). Reported adverse events included conjunctival hemorrhaging, increased intraocular pressure and blurred vision. Serious events such as intraocular inflammation and endophthalmitis were rare.1
The GA treatment landscape
Izervay is currently approved only in the United States. The treatment competes in a rapidly evolving GA treatment landscape. Syfovre® (pegcetacoplan; Apellis Pharmaceuticals, Massachusetts, USA), was the first FDA-approved GA therapy in early 2023 and remains a key competitor.
Other investigational therapies, including gene therapy approaches and dual inhibitors, are advancing through clinical trials, reflecting an increasing focus on slowing disease progression in GA.
With the label expansion, Izervay continues to offer retina specialists an important tool in the fight against geographic atrophy, a leading cause of irreversible vision loss in aging populations.
Reference
- Astellas Pharma. IZERVAY™ (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years. News release. November 6, 2023. Available at: https://www.astellas.com/en/news/28646. Accessed on February 14, 2025.
