Astellas Pharma Announces FDA Approval of Izervay (avacincaptad pegol), the First-in-Class Therapy for Geographic Atrophy Secondary to Age-Related Macular Degeneration

▎Edited by the WuXi AppTec content team

Recently, Astellas Pharma announced that the U.S. FDA has approved avacincaptad pegol intravitreal injection (brand name: Izervay) for the treatment of geographic atrophy (GA) caused by age-related macular degeneration (AMD).The press release noted that Izervay was the first to significantly reduce the progression rate of GA (p

Geographic Atrophy: A Leading Cause of BlindnessGeographic atrophy is an advanced form of age-related macular degeneration and a leading cause of blindness, affecting more than 5 million people worldwide. The disease progresses over an average of 2.5 years, gradually eroding the fovea, the central part of the macula responsible for central vision, severely impairing patients' visual function, independence, and quality of life. This condition results from irreversible damage to retinal cells caused by excessive complement activation.

Izervay is a complement C5 protein inhibitor developed by Iveric Bio. By targeting the C5 protein, Izervay has the potential to inhibit the activation of the complement system, thereby preventing retinal cell atrophy and the progression of geographic atrophy.On July 11, 2023, Astellas completed the acquisition of Iveric Bio.

Image Source: 123RF

This approval was based on the results of the pivotal phase 3 clinical trials, GATHER1 and GATHER2, which spanned 12 months. These two clinical trials evaluated the safety and efficacy of 2 mg Izervay administered intravitreally each month in patients with GA secondary to AMD. The study assessed the growth rate of GA in patients at baseline, 6 months, and 12 months. The primary analysis showed,Compared with the sham treatment, patients receiving Izervay showed a statistically significant reduction in the growth rate of GA. A slowing of disease progression was observed as early as 6 months, with a decrease in the GA growth rate of up to 35% during the first year of treatment.

In both trials, Izervay demonstrated a good safety profile. The most common adverse reactions (≥5%) were subconjunctival hemorrhage (bleeding under the transparent membrane of the eye: 13%), increased intraocular pressure (elevated fluid pressure in the eye: 9%), and blurred vision (8%).

References:

[1] Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy. Retrieved August 7，2023，from 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

[2] Astellas Completes Acquisition of Iveric Bio. Retrieved August 7，2023，from https://www.prnewswire.com/news-releases/astellas-completes-acquisition-of-iveric-bio-301874923.html