Aug 5, 2023

IZERVAY Approved by FDA for Treatment of Geographic Atrophy Secondary to Advanced Dry AMD

Eye On the Cure Research News

In two Phase 3 clinical trials, IZERVAY slowed the growth rate of lesions, the regions of cell loss in the central retina, associated with geographic atrophy (GA)

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Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to advanced dry age-related macular degeneration (AMD) on August 4, 2023. The treatment was developed by Iveric Bio which was acquired by Astellas in July 2023.

Astellas expects IZERVAY to be available in the US two to four weeks from the date of FDA approval. The treatment is administered through intravitreal injections — injections made in the soft gel in the middle of the eye — in a doctor’s office.

Astellas says that approximately 1.5 million people in the US have GA.

“We are excited to have a new treatment for geographic atrophy which is a leading cause of devastating central vision loss for people 55 and older,” says Jason Menzo, chief executive officer, Foundation Fighting Blindness. “IZERVAY has the opportunity to help people maintain their independence and quality of life by preserving their ability to read, drive, and see faces of loved ones.”

IZERVAY met the primary endpoint, slowing the growth rate of GA lesions, in two global Phase 3 clinical trials. In the 448-participant GATHER1 clinical trial, IZERVAY slowed lesion growth by 27.7 percent at 12 months of treatment. In the 286-participant GATHER2 clinical trial, IZERVAY slowed lesion growth by 14.3 percent at 12 months of treatment. In both trials, patients were randomized to receive either 2 mgs of IZERVAY or a sham monthly.

IZERVAY is designed to work by inhibiting the C5 protein, which is part of the complement system. Researchers believe that the overactive complement system, part of the innate immune system, is a key culprit in the development of AMD. While the complement system plays an important role in fighting off viruses, bacteria, and other pathogens, it can be damaging when overactive.

More than 10 million people in the US and 150 million worldwide have AMD. Vision loss from GA is caused by the accumulation of toxic deposits underneath the retina called drusen. The condition can cause loss of retinal pigment epithelial (RPE) cells which provide essential support for photoreceptors, the retinal cells that process light to make vision possible. The degeneration of RPE cells ultimately leads to loss of photoreceptors and central vision loss. In AMD, the macula, the central region of the retina, is affected most.