FDA Approves New Treatment for Geographic Atrophy: IZERVAY™ Offers Hope for Preserving Vision

FDA Approves New Treatment for Geographic Atrophy: IZERVAY™ Offers Hope for Preserving Vision

For individuals and families affected by inherited retinal diseases (IRDs) and related conditions, news of advancements in eye care is always met with anticipation. The U.S. Food and Drug Administration (FDA) recently approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval, announced on August 4, 2023, by Astellas Pharma Inc. and its subsidiary Iveric Bio, marks a significant step forward in addressing a condition that can lead to irreversible vision loss.

Geographic atrophy is a progressive and devastating disease that impacts an estimated 1.5 million people in the U.S. Its progression can severely limit a person's ability to drive, read, and recognize faces. The approval of IZERVAY™ offers a new therapeutic option for ophthalmologists and their patients.

Key Facts About IZERVAY™

• Mechanism of Action: IZERVAY™ is a new complement C5 inhibitor.
• Clinical Trial Success: The FDA approval was based on positive results from two Phase 3 clinical trials, GATHER1 and GATHER2. These were randomized, double-masked, sham-controlled, multicenter trials that evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY™ in patients with GA secondary to AMD.
• Significant Reduction in Progression: In both trials, IZERVAY™ demonstrated a statistically significant reduction (p < 0.01) in the rate of GA progression at the 12-month primary endpoint. Slowing of disease progression was observed as early as six months, with up to a 35% reduction in the first year of treatment.
• Safety Profile: Safety was evaluated in over 700 patients with GA across the two trials.
• Second Approved Treatment: IZERVAY™ is the second drug approved by the FDA for geographic atrophy, following the approval of another treatment in February.

What This Means for Patients and Families

The introduction of IZERVAY™ provides a new option for managing geographic atrophy, a condition that previously had limited treatment avenues. For patients, this approval means there is now another therapy available that has shown to slow the progression of GA, potentially preserving vision for a longer period. As Pravin U. Dugel, MD, President of Iveric Bio, an Astellas company, emphasized,