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FDA approves Izervay for geographic atrophy tied to age-related macular degeneration

FDA approves izervay for geographic atrophy tied to age-related macular degeneration

The U.S. Food and Drug Administration has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration.

The approval was based on two phase 3 , in which patients received 2 mg intravitreal administration of Izervay. During a 12-month follow-up period, there was a statistically significant reduction in the rate of geographic atrophy growth in patients treated with Izervay versus sham. Slowing of was detected as early as six months, with up to a 35 percent reduction in the first year of treatment.

At 12 months, the most common adverse reactions (≥5 percent) seen in patients who received Izervay 2 mg were conjunctival hemorrhage (13 percent), increased (9 percent), and blurred vision (8 percent).

"Geographic atrophy has a devastating impact on patients' lives and can lead to irreversible vision loss," Arshad M. Khanani, M.D., from Sierra Eye Associates in Reno, Nevada, said in a statement. "As a C5 inhibitor, Izervay has shown to slow geographic atrophy 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 geographic atrophy."

Approval of Izervay was granted to Iveric Bio, an Astellas Pharma company.

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Citation: FDA approves Izervay for geographic atrophy tied to age-related macular degeneration (2023, August 10) retrieved 28 November 2023 from
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