Second drug for dry AMD becomes available in the US
Izervay has become the second drug cleared by the US Food and Drug Administration to treat late-stage dry age-related macular degeneration. Here's what it means.
Published
A new medication designed to address late-stage dry age-related macular degeneration (AMD) has received approval for usage within the United States.
Known as Izervay (avacincaptad pegol), the drug has demonstrated its effectiveness in clinical trials by slowing down the progression of the disease during its advanced stages. It marks the second drug to receive clearance from the Food and Drug Administration (FDA) for utilization in the United States.
Formerly recognized as Zimura, Izervay functions by obstructing a specific protein called complement C5, which is thought to play a substantial role in exacerbating the condition. Researchers believe that this drug has the potential to reduce the activity leading to the deterioration of retinal cells, potentially impeding the advancement of late-stage dry AMD, also known as geographic atrophy (GA).
The FDA's approval comes following promising outcomes from Astellas' clinical trials, known as GATHER1 and GATHER2, encompassing over 700 participants with GA. These trials gauged the progression of the condition using advanced imaging techniques. The results demonstrated that individuals treated with Izervay exhibited a significant deceleration in disease progression when compared to those receiving a placebo.
Notably, the treatment's impact was noticeable within a mere six months, leading to up to a 35% reduction in GA progression during the initial year of treatment.
This marks the second FDA-approved drug for dry AMD in the US this year. Apellis Pharmaceuticals' pegcetacoplan, known as Syfovre, achieved this distinction earlier in February.
Geraldine Hoad, the research manager at the Macular Society, expressed her enthusiasm, stating, "Patients with late-stage dry AMD have waited a long time for any treatment, so it’s exciting to see this decision from the FDA so soon after approval of Syfovre earlier this year."
As for the implications of these developments for patients in the UK, Hoad added, "We don’t yet know what this means for patients in the UK but we will be keeping a close eye on any developments and hope these new drugs will become available in the coming months."
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