FDA Approves New Treatment for Geographic Atrophy

Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) has a new treatment option in Izervay (avacincaptad pegol), which was approved by the FDA on August 4, 2023. Izervay is a complement C5 inhibitor and is the only GA treatment that saw a statistically significant reduction in the progression of GA after 12 months.

GA affects more than 1.5 million people in the United States and more than 5 million people around the world. Although there had been treatments for wet AMD in the past, there had been no treatment options for people with GA secondary to AMD prior to this year.

This is the second treatment approved by the FDA to treat GA this year. Pegcetacoplan was approved in February and can treat GA through monthly and bimonthly injections. The monthly injection was found to reduce lesion growth by 22% compared with 18% when injected bimonthly in the OAKS Phase 3 trial. The DERBY Phase 3 trial found a similar result though the differences were less pronounced (18% vs 17% respectively).

Izervay, meanwhile, was found to have more efficient reductions compared with any currently approved medication. It was tested in 2 different Phase 3 clinical trials. The GATHER1 and GATHER2 trials evaluated the efficacy and safety of administering 2 mg intravitreal per month in patients who were diagnosed with GA that was secondary to AMD. There were 2 follow-ups after baseline at 6 and 12 months, where the rate of growth of GA was evaluated. Both trials found that there was a statistically significant reduction in the progression of GA when they were treated with Izervay compared with a placebo. Some patients saw a slowing of progression in 6 months and others had up to 35% reduction in the first year.

"Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss. 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,” Arshad M. Khanani, MD, MA, FASRS, the director of Clinical Research at Sierra Eye Associates, said in a press release.

The most common adverse reactions that occurred during the GATHER clinical trails were conjunctival hemorrhage (13%), intraocular pressure (9%), and blurred vision (8%). All other adverse reactions affected less than 5% of the trial population.

"We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the [United States],” said Pravin U. Dugel, MD, President of Iveric Bio, in the press release. “Time matters, vision matters, and safety matters in this devastating progressive disease. We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases."

The new medication is expected to become available to patients in the United States within a month.