Astellas Pharma has received conditional approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Izervay (avacincaptad pegol intravitreal solution: ACP) to suppress geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD).
Izervay is the first and only treatment approved for GA in Japan.
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In February 2025, the company submitted a new drug application to the MHLW seeking conditional approval for the therapy.
In the GATHER1 and GATHER2 global clinical trials, Izervay achieved its primary endpoint, reducing GA lesions’ growth rate compared to a sham procedure.
Over 12 months, the mean reduction in lesion growth was 35% in the GATHER1 study and 18% in GATHER2.
The treatment demonstrated sustained efficacy over a two-year follow-up period, with positive effects observed as early as six months after the initial injection.
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By GlobalDataIts safety profile was consistent across both trials, with fewer than 2% of subjects discontinuing treatment due to adverse events.
Astellas biopharma and ophthalmology development senior vice-president Marci English stated: “This approval highlights the strength of the GATHER clinical programme and the value of continued innovation in ophthalmology. Under the conditional approval system, we will build on these findings with confirmatory studies to further strengthen the evidence base and expand understanding of how to best help people living with geographic atrophy.”
Izervay operates by inhibiting the complement C5 protein, which plays a crucial role in the activation of the complement system that drives retinal cell degeneration. By slowing the growth of GA lesions, it is expected to decelerate visual impairment.
Astellas is now coordinating with the relevant authorities to ensure that patients can access Izervay as swiftly as possible.
The financial implications of approval have already been incorporated into the company’s financial projections for the fiscal year ending 31 March 2026.
