The US Food and Drug Administration (FDA) has provided expanded approval for Astellas Pharma Inc. to include Izervay (avacincaptad pegol intravitreal solution) in order to enable longer-term dosing in geographic atrophy (GA) therapy for age-related macular degeneration (AMD). This alteration removes previous restrictions on dosing duration, offering patients and those treating GA increased flexibility.

Key Highlights:
Expanded Label for Izervay:

• FDA approval authorizes longer-term dosing with Izervay for GA treatment.

• Izervay is the only FDA-approved treatment that has demonstrated statistically significant slowing of GA progression in two phase 3 clinical trials.

Regulatory Timeline:

• On December 26, 2024, Astellas re-submitted the supplemental New Drug Application (sNDA) following discussion with FDA regarding a Complete Response Letter (CRL) received in November 2024.

• The label expansion was authorized following consideration of favorable results from the GATHER2 phase 3 clinical trial.

Clinical Trial Findings:

• The GATHER2 trial revealed that Izervay reduced rates of GA lesion growth over two years, and benefit was demonstrated as early as six months.

• The treatment benefit grew incrementally over time and more than doubled in year 2 compared with year 1.

• Safety Profile: Izervay was found to be well tolerated with no cases of serious intraocular inflammation.

• Incidence of choroidal neovascularization was nominally higher among the Izervay group (11.6%) than the sham (9%).

Market and Financial Impact:

• 143,000 vials of Izervay have been sold in the US since Astellas secured a permanent J-code in April 2024 to September 2024.

• Effect on Astellas' FY 2024-25 financial results will be non-material.

Statements from Industry Experts:

• Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas Pharma:

"We are thrilled to receive FDA approval to expand Izervay for long-term use, further solidifying it as a go-to treatment for GA patients since its introduction in 2023."

• Dr. Veeral S. Sheth, Clinical Trials Director, University Retina:

"This is welcome news for retina specialists, providing sustained treatment options for GA patients, a progressive and chronic condition resulting in permanent loss of vision."

The FDA broadened approval of Izervay is a significant step in the treatment of geographic atrophy, providing long-term therapy options for patients with a strong safety profile. With increasing use among physicians, Izervay will be a key contributor to AMD treatment in the years ahead.