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- Avacincaptad pegol granted Priority Review status in China -
TOKYO, May 15, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for IZERVAY™ (avacincaptad pegol; ACP) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). ACP has also been granted Priority Review status in China.
GA is an advanced and irreversible form of AMD that leads to progressive vision loss and can significantly impact a patient’s independence and quality of life.1-3 In China, GA is estimated to affect approximately two million people, underscoring the need for new treatment options as the population ages.4
Shirley Zhao, President of Astellas China
“Geographic atrophy is a progressive condition that can significantly impact a patient’s vision and independence, yet treatment options remain limited. We are greatly encouraged by the swift acceptance of the NDA and the CDE’s decision to grant Priority Review for avacincaptad pegol, and we look forward to working closely with the relevant authorities to potentially bring this much-needed treatment option to patients in China.”
The NMPA accepted the NDA based on the high unmet medical need in GA patients, as well as results from the global pivotal GATHER1 and GATHER2 clinical trials, in which ACP met the primary endpoints by significantly reducing the rate of GA lesion growth compared with sham treatment.5,6 At 12 months, treatment reduced the mean rate of GA lesion growth by 35% in GATHER1 and 18% in GATHER2,7 with effects observed as early as six months and sustained over two years of follow-up.8 Across both trials, ACP was generally well tolerated, with low discontinuation rates due to adverse events.5,6
ACP is approved in the United States, Australia, Macao, and conditionally in Japan for the treatment of GA secondary to age-related AMD.
Astellas has already factored in the impact of this matter in its financial forecast for the current fiscal year ending March 31, 2027.
About avacincaptad pegol (ACP)
ACP is a synthetic aptamer that inhibits the complement C5 protein.9 Overactivity of the complement system and the C5 protein play a critical role in the development and growth of scarring and vision loss associated with GA secondary to AMD.9 By targeting C5, ACP is considered to decrease activity of the complement system known to cause the degeneration of retinal cells and thus slow the progression of GA.7
About Geographic Atrophy (GA)
GA is an advanced form of age-related macular degeneration (AMD) that leads to irreversible and progressive vision loss.2,9,10 It affects the macula, the central portion of the retina responsible for central vision. AMD is the leading cause of visual loss in people aged over 50 years old in developed countries.6
About the GATHER Clinical Trials
ACP met its primary endpoints in the GATHER1 Phase 2/3 clinical trial (NCT02686658) and the GATHER2 Phase 3 clinical trial (NCT04435366). These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either ACP 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials.
In year 2 of the GATHER2 study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). ACP was also studied in an 18-month open-label extension trial. During the open-label extension, GA patients who previously completed the GATHER 2 study switched from ACP EM or EOM treatment to ACP EM, or from sham to ACP EM.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
References
1. Boyer DS, et al. The pathophysiology of geographic atrophy secondary to age-related macular degeneration and the complement pathway as a therapeutic target. Retina. 2017;37(5):819-835.
2. Colijn JM, et al. Enlargement of Geographic Atrophy From First Diagnosis to End of Life. JAMA Ophthalmol. 2021;139(7):743-750.
3. Keenan TDL, Cukras CA, Chew EY. Age-Related Macular Degeneration: Epidemiology and Clinical Aspects. Adv Exp Med Biol. 2021;1256:1-31.
4. Wu J, et al. National, regional, and provincial prevalence of age-related macular degeneration in China in 2020: an updated systematic review and modelling study. J Glob Health. 2026;16:04062.
5. Khanani AM, et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458.
6. Jaffe GJ, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128(4):576-586.
7. IZERVAY™ (avancincaptad pegol intravitreal solution) Prescribing Information. March 2025.
8. Khanani AM, et al. GATHER2: Two-Year Data. Presented at AAO 2023 127th Annual Meeting. San Francisco, CA. 11-03-2023 to 11-06-2023.
9. Desai D and Dugel PU. Complement cascade inhibition in geographic atrophy: a review. Eye. 2022;36(2):294–302.
10. Ayoub T and Patel N. Age-related macular degeneration. J R Soc Med. 2009;102(2):56-61.
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