FDA Approves Expanded Label for Izervay, No Dosing Duration Limit

The FDA has approved an expanded label for Astellas’ Izervay (avacincaptad pegol intravitreal solution) to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a recent news release.

The new approval does not limit the duration of dosing. Previously, Izervay was approved for use for only 12 months, but now can be used longer than 12 months. Company executives said this provides physicians with greater flexibility when managing GA.

The updated label was approved using the results from the Gather2 phase 3 clinical trial, which studied the safety and efficacy of Izervay through two years of use. The study enrolled 448 patients. At the beginning of year two, 96 patients received Izervay every month, 93 patients received Izervay every other month and the patients who received placebo during year one continued to receive it in year two.

Monthly dosing through two years resulted in 14% yearly reduction in lesions, when compared with placebo. Dosing every other month after a year of monthly dosing resulted in a 19% reduction in lesions when compared with placebo, a separate news release reports.

During the trial, at least 5% of patients reported adverse reactions including one case of non-serious intraocular inflammation and culture-positive endophthalmitis each. The most common side effects were blood in the white of the eye, increased eye pressure and blurred vision. Izervay met its primary objective at 12 months with progress seen as early as six months. It is continuing to be evaluated in an open-label extension study.

Geographic atrophy is a progressive, advanced form of age-related macular degeneration, characterized by the development of lesions on the macula, which is the part of the retina responsible for detailed central vision. It affects about 1.5 million people in the United States and can lead to permanent vision loss.

First approved by the FDA on Aug. 4, 2023, Izervay is a complement C5 inhibitor that reduces the lesion progression rate. It is an intravitreal injection, meaning it is injected directly into the white of the eye, known as the vitreous humor. Because treatments may temporarily blur vision, patients should not drive or operate machinery until their vision clears.

Izervay received a permanent J-code in April 2024. On Dec. 26, 2024, Astrellas resubmitted the supplemental new drug application (sNDA).

"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, M.D., MBA, FACS, FASRS, partner and director of clinical trials at University Retina said in the news release.

The cost of Izervay is dependent on individual insurance coverage and other factors, according to a comment from an Astellas representative via email. More pricing information is available online.