FDA Expands Label for Izervay for GA Allowing for No Limitation on Duration of Dosing

The FDA has approved an expanded label for Astellas Pharma's geographic atrophy drug Izervay (avacincaptad pegol intravitreal solution), allowing the drug to be used without a limitation on duration of dosing. 

The approval, which provides physicians and patients greater flexibility when managing GA, follows Astellas’ resubmission of the supplemental new drug application (NDA) for Izervay on December 26, 2024, within days of meeting with the FDA to clarify the Agency’s feedback provided in the Complete Response Letter (CRL) issued in November 2024. 

“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, Biopharma and Ophthalmology Development, Astellas Pharma, said in a company news release. To date, Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies.”

The approved label update was based on positive results from the GATHER2 phase 3 clinical trial, which evaluated the efficacy and safety of Izervay through year 2. 

Since receiving a permanent J-code in April 2024, Izervay has had month-over-month growth in the US with more than 210,000 vials distributed through the end of December 2024, according to Astellas. Post-marketing safety reporting remains consistent with that observed in the clinical trial program, with no new or significant safety signals identified. 

The GATHER2 study demonstrated that Izervay continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with Izervay versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1. 

Izervay was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization was slightly increased between Izervay (11.6%) versus sham (9%). 

IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.