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Iveric Bio Receives US FDA Approval for IZERVAY™

Saturday, August 05, 2023

Iveric Bio, an Astellas Company, has received FDA approval for IZERVAY™ (avacincaptad pegol intravitreal solution) as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

IZERVAY is the only approved GA treatment to show a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials is certainly promising.

This approval offers a new therapeutic option for patients dealing with this challenging condition and could potentially provide them with better outcomes and improved vision-related outcomes.

IZERVAY is described as a complement C5 inhibitor, which targets the source of retinal cell death and may help preserve the benefits of the complement system, thereby potentially extending patients' ability to maintain their independence and quality of life.

IZERVAY's approval is based on the positive results from the GATHER1 and GATHER2 Phase 3 clinical trials, where the treatment demonstrated its safety and efficacy in slowing the progression of GA in patients with AMD.

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