FDA Approves Izervay to Treat Geographic Atrophy

The FDA has approved Izervay (avacincaptad pegol) to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is administered with an intravitreal injection, which places the medication in the space at the back of the eye.

Izervay is a complement C5 inhibitor. Overactivity of the complement system and the C5 protein are thought to play a role in the scarring and vision loss associated with geographic atrophy, which affects about 1.5 million people in the United States. The therapy was developed by Iveric Bio, which was recently acquired by Astellas.

Izervay is expected to be available within the two to four weeks. it will have a wholesale acquisition cost of $2,100 per vial. About 90% of patients are expected to be Medicare beneficiaries, according to a spokesperson.

Arshad M. Khanani, M.D.

“Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss,” Arshad M. Khanani, M.D., director of clinical research at Sierra Eye Associates in Reno, said in a press 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 approval was based on the GATHER1 and GATHER2 phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal injections. Over a 12-month period in both trials, Izervay showed a statistically significant reduction in the rate of geographic atrophy growth. Slowing of disease progression was observed as early as six months with up to a 35% reduction in the first year of treatment.

The most common adverse reactions were bleeding beneath the clear lining of the eye, intraocular pressure and blurred vision.

This story originally appeared on Managed Healthcare Executive.