FDA Approves Izervay for Geographic Atrophy

IZERVAY: FDA Approves First Drug for Geographic Atrophy

Source – Astellas Pharma

Astellas Pharma has received FDA approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. Izervay is a novel complement C5 inhibitor and is now the only approved treatment for GA with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint, as demonstrated in two Phase III clinical trials.

The FDA’s decision was based on the positive results from the GATHER1 and GATHER2 Phase III clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. The data showed a significant reduction in the rate of GA growth compared to the sham group over a 12-month period, with an early indication of disease progression slowing as early as 6 months of treatment, achieving up to a 35% reduction in the first year.

“We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US. 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.”

– Pravin U. Dugel, MD, President, Iveric Bio, An Astellas Company

GA is a significant concern, affecting an estimated 1.5 million people in the US, with a concerning 66% risk of becoming blind or severely visually impaired without timely treatment. However, approximately 75% of those affected are believed to be undiagnosed, highlighting the need for increased awareness and diagnosis.

The most common adverse reactions reported at 12 months in patients who received Izervay 2 mg were conjunctival hemorrhage (13%), increased intraocular pressure (9%), and blurred vision (8%).

Izervay is expected to become available in the US within the next 2-4 weeks, offering new hope for patients with GA. Astellas is currently assessing the potential financial impacts of this approval for the fiscal year ending March 31, 2024.

“Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss. 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 FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

– Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada

This FDA approval marks a significant milestone in the treatment of GA secondary to AMD, providing patients with a promising therapeutic option to slow disease progression and preserve vision. The positive clinical trial results demonstrate the efficacy and safety of Izervay, bringing much-needed relief to those suffering from this debilitating condition. As awareness increases and diagnosis rates improve, the widespread availability of Izervay has the potential to transform the lives of patients and reduce the burden of visual impairment caused by GA.

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