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15th Annual Congress on Controversies in Ophthalmology (COPHy 2024)

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Aug 8, 2023

Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy

NEWS PROVIDED BY Astellas Pharma Inc. 04 Aug 2023, 21:24 ET

IZERVAY 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 3 clinical trials

IZERVAY slowed the loss of photoreceptors and disease progression as early as six months

GA impacts an estimated 1.5 million people in the U.S. and can cause irreversible vision loss

TOKYOAug. 5, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. IZERVAY, a new complement C5 inhibitor, is the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.

Pravin U. Dugel, MD, President, Iveric Bio, An Astellas Company
“We are thrilled to receive FDA approval of IZERVAY and to offer a new therapy to physicians and appropriate patients in the U.S. 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 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD. The rate of GA growth was evaluated at baseline, 6 months, and 12 months. In each registrational trial, over a 12-month period, the primary analysis 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 6 months with up to a 35% reduction in the first year of treatment….

Read more: https://www.prnewswire.com/news-releases/iveric-bio-receives-us-fda-approval-for-izervay-avacincaptad-pegol-intravitreal-solution-a-new-treatment-for-geographic-atrophy-301894042.html?tc=eml_cleartime

Source: Cision PR Newswire

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