In August 2023, Astellas Pharma Inc. announced it had received FDA approval for its IZERVAY treatment for geographic atrophy (GA). IZERVAY (avacincaptad pegol intravitreal solution) is now the only FDA-approved treatment for GA that showed a statistically significant reduction in GA progression after 12 months in two Phase 3 trials.
GA is a severe disease characterized by the death of pigmented cells in the retina, causing patches of dead cells. Over time, more cell death occurs, causing irreversible vision loss. Research has shown that 1.5 million people in the United States have GA, while 75 percent are undiagnosed. Without timely treatment, about 66 percent of these people will become visually impaired or blind.
IZERVAY is a promising treatment that showed it can slow the progression of GA by mitigating retinal cell death. The FDA approved IZERVAY after it posted positive results in its GATHER1 and GATHER2 clinical trials. Both trials were randomized and multi-center.
In the trials, researchers first took baseline GA measurements of patients and then randomly administered either 2mg of IZERVAY or a sham. The researchers followed up with more measurements after six and 12 months. In both trials, GA growth reduced significantly. Researchers recorded a slowdown as early as six months by up to up to 35 percent.
