
FDA approves amended label for Izervay for geographic atrophy
Key Takeaways
- The FDA approved an expanded label for avacincaptad pegol, allowing flexible dosing for GA management in AMD patients.
- A revised NDA submission included positive two-year data from the GATHER2 Phase 3 trial, leading to the expanded approval.
The approval follows a refiling after the FDA issued a Complete Response Letter due to language on the amended label.
The FDA approved a new, expanded version of the US Prescribing information for avacincaptad pegol intravitreal solution (Izervay; Astellas Pharma) for the treatment of
In November 2024, the
"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,” Marci English, senior vice president of biopharma and ophthalmology development at Astellas Pharma, said in a press release. “To date, IZERVAY remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies."
The avacincaptad pegol intravitreal injection was
"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," Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of clinical trials at University Retina, said in a press release.
Reference
U.S. FDA approves expanded label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for geographic atrophy. PR Newswire. Press release. Published February 12, 2025. Accessed February 13, 2025.
https://www.prnewswire.com/news-releases/us-fda-approves-expanded-label-for-astellas-izervay-avacincaptad-pegol-intravitreal-solution-for-geographic-atrophy-302375403.html?tc=eml_cleartime
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