Oral presentation highlights early progress of investigational ASP7317 in the treatment of advanced geographic atrophy

Encore oral presentation features long-term outcomes for IZERVAY^® (avacincaptad pegol intravitreal solution) in GA secondary to AMD

Additional data provide insights into patient behavior, functional outcomes, disease prevalence, and retinal disease mechanisms

NORTHBROOK, Ill., April 30, 2026 /PRNewswire/ — Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) today announced new research insights for geographic atrophy (GA) that will be presented at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO), May 3-7, Denver, Colorado.

A total of nine abstracts feature an oral presentation of preliminary Phase 1b results for ASP7317, an investigational retinal cell-based therapy for advanced GA. An encore oral presentation will highlight long-term safety and efficacy findings for IZERVAY for the treatment of GA secondary to age-related macular degeneration (AMD).

Additional data highlights include:

• IZERVAY’s impact on maintenance of driving eligibility
• IZERVAY’s mechanism of action
• IZERVAY’s pharmacokinetics and immunogenicity after IVT injection
• Findings on treatment-seeking behavior of patients with GA

Insights from an epidemiology study of Stargardt‑type macular dystrophies, a group of rare inherited retinal diseases that lead to progressive vision loss, will also be presented.

Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma
“At Astellas, we are deeply committed to advancing science that can meaningfully change the trajectory of vision-threatening retinal diseases. The breadth of data we are presenting at ARVO underscores our continued focus on innovation, including novel pipeline candidates like our investigational cell therapy ASP7317. At the same time, we remain focused on helping improve long-term outcomes in GA with IZERVAY. Together, these efforts reflect our determination to better understand and treat serious retinal conditions and make a significant difference for patients.”

Astellas Presentations at 2026 ARVO Annual Meeting

Oral Presentations

Poster Presentations

ASP7317 is an investigational retinal pigment epithelium (RPE) cell therapy derived from human embryonic stem cells, currently being evaluated in a multicenter, open-label, dose-escalation Phase 1b trial for the treatment of advanced GA. It is one of the first ophthalmic cell therapies derived from pluripotent stem cells to enter the clinic. Safety and efficacy have not yet been established, and there is no guarantee the agent will receive regulatory approval or become commercially available for the use(s) being investigated.

IZERVAY is approved for the treatment of GA in the United States, Australia, Macau and conditionally in Japan. Astellas continues to engage with regulatory authorities around the world to bring ACP to GA patients globally.

About IZERVAY^® (avacincaptad pegol intravitreal solution)

IMPORTANT SAFETY INFORMATION AND USE

Do NOT receive IZERVAY^® (avacincaptad pegol intravitreal solution) if you:

• Have an infection in or around your eye
• Have active swelling in or around your eye that may include pain and redness

IZERVAY can cause serious side effects including:

• Eye Infection and Retinal Detachment: Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).
• Wet Age-Related Macular Degeneration (AMD): There is a risk of developing wet age-related macular degeneration (AMD) with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.
• Increase in Eye Pressure: IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.

Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.

Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:

• Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
• Have high pressure in the eye or if you have glaucoma.
• Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.

What should I avoid while receiving IZERVAY?

• Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.

What are the most common side effects of IZERVAY?

• Blood in the white of the eye
• Blurred vision
• Increase in eye pressure
• Wet AMD
• Mild corneal irritation
• Eye pain

These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is IZERVAY?
IZERVAY is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry AMD.

Please see accompanying full Prescribing Information.

About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, a loss of retinal cells occurs, resulting in a marked thinning and/or atrophy of retinal tissue. Geographic atrophy, an advanced stage of AMD, is a progressive disease that leads to irreversible loss of vision. 

About the GATHER Clinical Trials
IZERVAY met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either IZERVAY 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 IZERVAY in year 1 were re-randomized to receive either IZERVAY 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). IZERVAY 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 IZERVAY EM or EOM treatment to IZERVAY EM, or from sham to IZERVAY 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.

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SOURCE Astellas Pharma Inc.