FDA Approves Amended Label for Izervay in the Treatment of Geographic Atrophy

The FDA has approved an amended label for avacincaptad pegol intravitreal solution (Izervay; Astellas Pharma), expanding its use for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval removes limitations on the duration of dosing, offering greater flexibility for both patients and eye care providers in managing GA.

FDA Approval Process and Background

In November 2024, the FDA issued a Complete Response Letter (CRL) for a supplemental New Drug Application (NDA) for Izervay, citing concerns regarding the label language. Following a meeting with the FDA on December 20, 2024, Astellas Pharma refiled the NDA on December 26, 2024, incorporating the agency’s feedback.

The supplemental NDA included positive two-year data from the GATHER2 Phase 3 clinical trial, which evaluated the safety and efficacy of monthly and every-other-month dosing of avacincaptad pegol for GA treatment.

Enhanced Flexibility in GA Management

With the FDA’s updated label approval, Izervay’s duration of dosing is no longer restricted, allowing clinicians to tailor treatment plans according to individual patient needs.

Marci English, Senior Vice President of Biopharma and Ophthalmology Development at Astellas Pharma, commented on the approval:

"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."

Izervay’s Market Presence and Safety Profile

First approved by the FDA in August 2023, Izervay received its permanent J-code in March 2024. By the end of December 2024, over 210,000 vials of avacincaptad pegol had been distributed.

Post-marketing safety data has remained consistent with clinical trial results, with no new or significant safety signals reported since Izervay’s launch.

Clinical Impact and Future Outlook

Dr. Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of clinical trials at University Retina, welcomed the update:

"This is a welcome update for retina specialists, providing continued management options for the treatment of this chronic, progressive disease that can lead to irreversible vision loss."

With its amended label and robust clinical data, Izervay continues to be a critical treatment option for GA, offering long-term management solutions and improving patient outcomes in the fight against vision loss caused by AMD.