Astellas Pharma announced that China’s NMPA has accepted and granted Priority Review to the NDA for IZERVAY™ (avacincaptad pegol; ACP) for geographic atrophy secondary to age-related macular degeneration, supported by positive GATHER1 and GATHER2 trial data showing reduced GA lesion growth.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for IZERVAY™ (avacincaptad pegol; ACP) for the treatment of geographic atrophy (GA) secondary to age‑related macular degeneration (AMD). The submission has been granted Priority Review by the Center for Drug Evaluation (CDE).
GA is an advanced, irreversible form of AMD that progressively damages the macula, leading to vision loss and reduced independence. In China, GA affects an estimated two million people, underscoring a significant unmet need in the aging population.
The NDA is supported by pivotal data from the Phase 2/3 GATHER1 (NCT02686658) and Phase 3 GATHER2 (NCT04435366) trials. Both studies met their primary endpoint, showing that monthly 2 mg intravitreal injections of ACP significantly slowed GA lesion growth compared with sham treatment.
- In GATHER1, ACP reduced mean GA lesion growth by 35% at 12 months.
- In GATHER2, ACP achieved an 18% reduction at 12 months. Treatment effects were evident by month six and sustained through two years. ACP was generally well tolerated, with low discontinuation rates due to adverse events.
In year two of GATHER2, ACP‑treated patients were re‑randomized to monthly or every‑other‑month dosing, while sham patients continued sham treatment. ACP is also being evaluated in an 18‑month open‑label extension study.
ACP is a synthetic aptamer targeting complement C5, a protein implicated in retinal cell degeneration and GA progression. By inhibiting C5, ACP aims to slow retinal damage and disease progression.
ACP is currently approved in the United States, Australia, and Macao, and has conditional approval in Japan. Shirley Zhao, President of Astellas China, stated: “We are encouraged by the rapid NDA acceptance and Priority Review designation. Astellas will work closely with Chinese regulators to potentially bring this treatment to patients with GA in China.”
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About the Writer
Nikita Jha, BPharm (LinkedIn) a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.