Astellas Pharma Inc

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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-to-highlight-new-findings-for-geographic-atrophy-at-arvo-2026-annual-meeting-302758002.html

SOURCE Astellas Pharma Inc.

- Astellas and Vir Biotechnology to co-develop and co-commercialize VIR-5500 through a sharing of expenses and revenues -

- Astellas to lead commercialization of VIR-5500 in the U.S. with Vir Biotechnology retaining option to co-promote, and Astellas will obtain exclusive rights to commercialize VIR-5500 ex-U.S. -

- Vir Biotechnology will receive $335M in upfront and near-term milestone payments, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37B in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales -

- Vir Biotechnology to host conference call today at 2:30 p.m. PT / 5:30 p.m. ET -

TOKYO and SAN FRANCISCO, Feb. 23, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced they have entered into a global strategic collaboration to advance VIR-5500, an investigational PRO-XTEN^® dual-masked CD3 T-cell engager (TCE) targeting PSMA for the treatment of prostate cancer. The collaboration aims to accelerate the development of VIR-5500 and further strengthen Astellas' oncology pipeline and prostate cancer leadership.

Adam Pearson, Chief Strategy Officer, Astellas

"Astellas is proud to have helped 1.5 million patients with prostate cancer, and we are dedicated to expanding our impact as part of our R&D strategy. Our deep expertise in this disease area, combined with a growing immuno-oncology (IO) pipeline of biologics, including T-cell engagers, uniquely positions us to help advance VIR-5500, a potentially best-in-class T-cell engager for prostate cancer. This strategic collaboration allows Astellas and Vir Biotechnology to combine our expertise and reaffirms our commitment to improving the lives of people with prostate cancer."

Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology

"Astellas is an ideal collaborator for the VIR-5500 program given the company's successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value to patients through strategic development alliances with other biotech partners. This collaboration will enable more rapid advancement of VIR-5500 to potentially benefit more people living with prostate cancer. We believe this collaboration reflects confidence in our PRO-XTEN^® platform, which has broad potential across multiple solid tumor indications."

Despite recent advances in treatment, prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC), remains an aggressive and difficult cancer to treat; mCRPC has a 5-year survival rate of approximately 30%.ⁱ Patients who progress to mCRPC develop therapeutic resistance and currently have limited treatment options.

VIR-5500 is a potential best-in-class dual-masked Prostate-Specific Membrane Antigen (PSMA)-targeting TCE and is currently in Phase 1 development for people with advanced, metastatic prostate cancer (NCT05997615). VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN^® masking technology, which is designed to keep the TCEs masked (or inactive) until they reach the tumor microenvironment, reducing off-target effects and improving the therapeutic index.

Under the terms of the agreement, Vir Biotechnology will receive $335 million in upfront and near-term payments, including $240 million in cash, $75 million in equity investment at a 50% premium,ⁱⁱ and a near-term $20 million milestone. Global development costs for VIR-5500 will be shared, with Astellas responsible for 60% and Vir Biotechnology responsible for 40% of all costs. Vir Biotechnology will continue the ongoing Phase 1 trial, until responsibility is transitioned to Astellas, after which Astellas will be responsible for all development activities. In the U.S., Vir Biotechnology will have the option to co-promote VIR-5500 with Astellas, and profit/loss will be shared equally. Outside the U.S., Astellas will be exclusively responsible for commercialization of VIR-5500. In addition, Vir Biotechnology is eligible to receive up to $1.37 billion in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, a portion of certain collaboration proceeds will be shared with Sanofi. 

Lazard acted as Vir Biotechnology's exclusive financial advisor. Closing of the transaction is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act. 

Vir Biotechnology Conference Call

Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 2:30 p.m. PT / 5:30 p.m. ET today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.

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.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN^® dual-masked T-cell engagersⁱⁱⁱ across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. 

Footnotes:

ⁱHuo, Xingyue et al. "Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram." Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070

ⁱⁱ50% premium to the 30 day volume weighted average share price as of February 19, 2026

ⁱⁱⁱVir Biotechnology retains exclusive rights to the PRO-XTEN^® masking platform for oncology and infectious disease. PRO-XTEN^® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

Astellas 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.

Vir Biotechnology Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "should," "could," "may," "might," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of VIR-5500 to treat prostate cancer (including mCRPC) and Vir Biotechnology's belief that it can be a best-in-class PSMA-targeting TCE; Vir Biotechnology's clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology's immediate and potential future financial and other obligations under the agreement and collaboration with Astellas, as well as Vir Biotechnology's ability to realize the benefits; Vir Biotechnology's belief that Astellas is an ideal collaborator (given Astellas' successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value through strategic development alliances) and that the agreement will enable faster and broader advancement of VIR-5500 to potentially benefit more people living with prostate cancer; the timing of the anticipated closing of the transaction with Astellas, including receipt of any necessary regulatory clearances; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology's various collaborations can ultimately be achieved; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology's available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-and-vir-biotechnology-announce-global-strategic-collaboration-to-advance-psma-targeting-pro-xten-dual-masked-t-cell-engager-vir-5500-for-the-treatment-of-prostate-cancer-302694866.html

SOURCE Astellas Pharma Inc.