Astellas gains Japan approval for IZERVAY, first GA treatment

Astellas Pharma Inc. announced today that Japan's Ministry of Health, Labor and Welfare has granted Conditional Approval for IZERVAY (avacincaptad pegol intravitreal solution: ACP). This makes ACP the first and only approved treatment in Japan for suppressing geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD). The approval was expedited due to serious unmet medical need.

The company stated that the impact of this approval is already reflected in its financial forecast for the current fiscal year ending March 31, 2026. ACP, a complement C5 inhibitor, significantly reduced GA lesion growth in global GATHER1 and GATHER2 clinical trials, with mean reductions of 35% and 18% over 12 months, respectively.

GA is an advanced, irreversible form of AMD leading to progressive vision loss, estimated to affect nearly 100,000 people in Japan. Without timely treatment, approximately 66% of GA patients risk blindness or severe visual impairment.