Pooled post hoc analysis of GATHER1 and GATHER2 showed IZERVAY® (avacincaptad pegol intravitreal solution) reduced the risk of progressing to loss of driving eligibility compared with sham over 24 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Encore GATHER2 open-label extension data demonstrated IZERVAY was well-tolerated, with no new safety signals, and earlier intervention with IZERVAY resulted in slowing GA with greater protection of healthy retinal tissue

NORTHBROOK, Ill., May 12, 2026  /PRNewswire/ — Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”), today announced results from a post hoc analysis of the GATHER1 and GATHER2 pivotal studies, showing treatment with IZERVAY reduced the risk of progressing to loss of driving eligibility compared with sham over 24 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The findings, presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Denver, Colorado, suggested treatment benefits of IZERVAY increased over time.

Key findings:

• At the start of the study, participating patients (n=403) who either received IZERVAY or sham had similar vision (76.2 letters vs. 76.0 letters)
• At 24 months, the risk of progressing to loss of driving eligibility was 12.6% for IZERVAY monthly (EM) or every-other-month (EOM) compared to 20.1% for sham, representing a 41% relative risk reduction for IZERVAY (nominal p-value=0.0594)
• Similar results were seen for patients who switched from IZERVAY EM to EOM dosing*
• When analyzing IZERVAY EM dosing only vs. sham, the risk of progressing to loss of driving eligibility was 15.1% for IZERVAY compared to 20.1% for sham, a 35% reduction in relative risk (nominal P-value=0.1584)
• Given the exploratory post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive

In the GATHER1 study, patients received IZERVAY EM or sham for 18 months. In the GATHER2 trial, patients were given IZERVAY EM or sham for 12 months, after which they were re-randomized to IZERVAY EM or EOM up to 24 months. This post hoc analysis included patients who were eligible to drive at baseline, defined by best-corrected visual acuity (BCVA) of ≥70 ETDRS letters. The study assessed the risk of progressing to loss of driving eligibility, defined as ≤60 letters seen at two consecutive post-baseline visits, over a 24-month period in the study eye.

Margaret Chang, MD, MS, Retinal Consultants Medical Group, Sacramento, Calif
“Geographic atrophy is a progressive disease associated with vision loss that can affect many aspects of daily life, including the ability to drive. Findings from this study suggest IZERVAY slows GA progression, which could allow some patients to continue to do the things they love for longer.”

Separately, an oral encore presentation of the GATHER2 open-label extension (OLE) study in patients with GA secondary to AMD demonstrated IZERVAY was well-tolerated with no new safety signals, no cases of retinal vasculitis or occlusive vasculitis, and no increased risk of intraocular inflammation.

Exploratory, longer-term data from the GATHER 2 OLE also showed IZERVAY’s sustained slowing of GA lesion growth over time, with earlier intervention resulting in greater protection of healthy retinal tissue area. Mean change in GA lesion growth area from months 24 to 42 was reduced by 40.5% vs. projected sham in participants who switched from IZERVAY EM or EOM to IZERVAY EM at 3.5 years, and by 37% vs. projected sham in the IZERVAY EM group who previously received sham (p<0.001 for each).

Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma
“At Astellas, we remain committed to advancing the science of geographic atrophy and strengthening the body of evidence behind IZERVAY. These findings—highlighting sustained slowing of disease progression and the potential impact on vision-dependent functions like driving—reflect our focus on developing therapies that can make a meaningful difference for people living with GA.”

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.

*The recommended dose for IZERVAY is 2 mg once monthly (approximately 28 +/- 7 days).

About IZERVAY^® (avacincaptad pegol intravitreal solution)

U.S. 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 a 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 endpoints 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.