The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials.
Pravin Dugel, President, Iveric Bio (An Astellas Company), said: “We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US. 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 FDA approval was based on the GATHER1 and GATHER2 Phase III clinical trials, which 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 six months with up to a 35% reduction in the first year of treatment.
Arshad Khanani, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, said: “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.”
GA impacts an estimated 1.5 million people in the US. Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World
