The US FDA has approved a new expanded label for Astellas Pharma’s IZERVAY™ (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) due to age-related macular degeneration (AMD) long-term. The expansion provides physicians and patients with more options for treating this progressive and chronic eye disease, which can cause irreversible vision loss.
The approval results from Astellas’ resubmission of its application to the FDA in December 2024 after addressing initial feedback. IZERVAY, initially approved in 2023, is still the only FDA-approved therapy proven to significantly reduce the progression of GA. The expanded approval is based on encouraging findings from the GATHER2 Phase 3 clinical trial, showing IZERVAY’s safety and efficacy after two years.
The GATHER2 trial confirmed that IZERVAY substantially slowed the growth of GA lesions compared to a sham (placebo) treatment. Benefits were observed as early as six months and increased further over two years. The treatment’s impact more than doubled in the second year compared to the first. Patients tolerated the treatment well, with an extremely low number of reports of side effects like mild eye inflammation or infection. Over two years, the incidence of new growth of blood vessels in the eye (choroidal neovascularization) was slightly higher in the IZERVAY group than in the sham group (11.6% vs. 9%).
Since its launch, IZERVAY has been steadily growing in use in the US, with over 210,000 vials dispensed through the end of 2024. Its safety during real-world use is consistent with clinical trial findings, allowing physicians to feel secure in prescribing the drug.
Retina experts such as Dr. Veeral Sheth were optimistic about the news, which they said offers much-needed alternatives for the treatment of GA. The approval also makes IZERVAY a top option for patients who are fighting this incapacitating disease, providing hope for improved long-term outcomes. Astellas does not anticipate that this approval will meaningfully impact its current fiscal year’s financials.
Source: www.astellas.com/en/news/29641
