Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has approved its label extension application for Izervay (avacincaptad pegol intravitreal solution). The approval allows the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without any limitation on the duration of dosing administration.
Drug Background and Previous Approval
Izervay, a synthetic aptamer that inhibits the complement C5 protein, was first approved in the US in August 2023 for use in GA secondary to AMD. The recent label update approval by the FDA is a significant step forward for the drug’s application in the treatment of this condition.
Approval Based on Positive Study Results
The FDA’s decision for the label update was based on the positive results from the Phase III GATHER2 study. The study assessed the two-year efficacy and safety of Izervay treatment. The results showed that Izervay continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years compared to sham treatment. The treatment benefit with Izervay versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.
Safety Profile
In addition to its efficacy, Izervay also demonstrated a good safety profile over the 2-year study period. It was well-tolerated by patients, with zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. This further strengthens the potential of Izervay as a safe and effective treatment option for patients with GA secondary to AMD.-Fineline Info & Tech
