Iveric Bio, an Astellas company, announced on August 5 that it has earned US Food and Drug Administration (FDA) approval for Izervay (avacincaptad pegol intravitreal solution) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The drug is the second to be approved to treat GA, after the February 2023 approval of pegcetacoplan (Syfovre; Apellis Pharmaceuticals). Izervay is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across 2 phase 3 clinical trials. Notably, the treatment showcased efficacy by slowing the loss of photoreceptors and impeding disease progression as early as 6 months.

The FDA approval was based on the GATHER1 and GATHER2 phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. The rate of GA growth was evaluated at baseline, 6 months, and 12 months. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with Izervay compared to sham. Slowing of disease progression was observed as early as 6 months with up to a 35% reduction in the first year of treatment.

Across the GATHER clinical trial program, the most common adverse reactions (≥5%) reported at 12 months in patients who received Izervay 2 mg were conjunctival hemorrhage (13%), intraocular pressure (9%) and blurred vision (8%).

“Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss,” trial investigator Arshad M. Khanani, MD, MA, FASRS, director of clinical research at Sierra Eye Associates in Reno, Nevada, said in a news release. “As a C5 inhibitor, Izervay has shown to slow GA progression by targeting the source of retinal cell death and may preserve the upstream benefits of the complement system. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

Izervay is anticipated to be available in the United States in 2 to 4 weeks.