Avacincaptad pegol

Inflammasome Therapeutics reported six-month Phase II results showing its investigational drug K8 slowed geographic atrophy lesion growth by more than half in the trial’s mid-dose cohort, according to a press release issued by the Massachusetts-based company. The K8 geographic atrophy data, presented at the American Society of Retina Specialists meeting in Montreal, also showed a statistically significant visual-acuity advantage over control eyes — an endpoint neither of the two currently approved GA therapies met in their pivotal trials. For a disease with no cure and only modest treatment options, a signal of preserved vision alongside slower lesion growth addresses a key limitation of existing therapies and may warrant advancement into late-stage development. Geographic atrophy is an advanced form of dry age-related macular degeneration marked by progressive death of retinal tissue, affecting an estimated eight million people worldwide. K8 (kamuvudine-8) is a dual inflammasome inhibitor delivered as a bioerodible, sustained-release intravitreal implant dosed once every three months; it is designed to block inflammasome activation triggered by multiple toxic drivers of GA — including complement, retrotransposons and oxidative stress — rather than a single upstream pathway. K8 remains fully investigational and has not been approved by the FDA or any other regulatory authority. The multicenter Phase II trial enrolled 30 participants with bilateral GA across nine US centers — 60 eyes total, with the worse-seeing eye receiving a K8 implant and the fellow eye serving as an untreated control. Three doses (0.3 mg, 0.7 mg, 1.05 mg) were tested, administered at baseline and again at month three. In the 0.7 mg cohort, the mean rate of GA lesion growth was 54% lower than in the pooled control group over six months (p\=0.016), using the FDA-preferred linear mixed-effects slope model. A prespecified analysis restricted to eyes with extrafoveal lesions — those with the greatest potential for vision preservation — showed a covariate-adjusted 4.0-letter mean BCVA advantage for K8-treated eyes versus controls (p\=0.004); BCVA changes were positive at every visit in the K8 group and negative at every visit in controls. No drug-related serious adverse events or dose-limiting toxicities were reported through month six, and there were no cases of endophthalmitis, intraocular inflammation, neovascular AMD, retinal vasculitis or optic neuropathy. The results extend an earlier readout from the same trial, which showed a 66% reduction in lesion growth at three months in an initial five-patient cohort — a result the company used to justify expanding enrollment to 60 eyes. Two therapies are approved in the US for GA: Apellis Pharmaceuticals’ Syfovre (pegcetacoplan), a complement C3 inhibitor cleared in February 2023, and Astellas’ Izervay (avacincaptad pegol), a complement C5 inhibitor approved in August 2023. Both require monthly or near-monthly intravitreal injections and reduced GA lesion growth by roughly 13-14% versus control over their first six months of dosing, without demonstrating a visual-acuity benefit in Phase III testing. Neither has secured EMA approval, reportedly reflecting European regulators’ emphasis on functional vision outcomes rather than anatomic lesion measures alone. Inflammasome Therapeutics frames the 54% growth reduction and paired BCVA signal as clearing “a high bar” relative to those benchmarks, though the comparison is cross-trial rather than head-to-head, and the underlying patient populations, endpoints and control designs differ. The dosing interval is a further point of contrast. K8’s implant is designed for administration every three months, versus monthly injections for the approved complement inhibitors — a difference that, if durability holds up in larger studies, could reduce the treatment burden that has limited real-world uptake of existing GA therapies. The fellow-eye control design used in this trial, where each patient serves as their own comparator, also strengthens the internal consistency of the result, since natural-history data cited by the company indicate GA progresses at nearly identical rates between a patient’s two eyes absent treatment. The visual-acuity finding is what distinguishes this readout from prior GA trials. Both approved drugs demonstrated anatomic effects — slower lesion expansion — without translating into measurable functional benefit, a disconnect that has tempered enthusiasm among retina specialists about their real-world impact. If replicated in larger, randomized studies, a therapy that demonstrates both slower structural loss and preserved visual function would address one of the principal limitations of existing GA treatments Caution is warranted given the sample size: the BCVA analysis was conducted in just 30 eyes (14 treated, 16 control), and the primary efficacy analysis, while statistically significant, comes from a single Phase II study rather than a confirmatory trial. Inflammasome Therapeutics has said it plans to move directly into a global Phase III pivotal program. Access the AllSci platform to explore the science behind the news. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Late-breaking oral presentation highlights early signals of potential visual improvement and patient-reported outcomes of investigational ASP7317 in patients with advanced geographic atrophy (GA) Podium presentation focuses on the impact of IZERVAY® (avacincaptad pegol intravitreal solution) on GA biomarker ellipsoid zone integrity Additional IZERVAY data highlight encore findings on driving eligibility, provide further GA biomarker insights and examine real-world treatment patterns in patients receiving anti-VEGF therapy NORTHBROOK, Ill., July 9, 2026 /PRNewswire/ -- Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") today announced new research insights at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting, July 15-18, Montreal, Canada, that further advance understanding for geographic atrophy (GA) that will be presented. A late-breaking oral presentation will highlight preliminary Phase 1b results for ASP7317, an investigational retinal cell therapy for advanced GA and one of the first pluripotent stem cell-derived ophthalmic cell therapies to be tested in clinical trials. The presentation will include information on early signals of potential visual improvement, anatomical stabilization and patient-reported outcomes. Astellas' IZERVAY (avacincaptad pegol intravitreal solution), indicated for the treatment of GA secondary to age related macular degeneration (AMD), will also have a podium presentation revealing emerging data on the relationship between ellipsoid zone integrity (an earlier biomarker for GA measuring photoreceptor health) and low-luminance deficit. Additional IZERVAY data will further explore biomarkers associated with disease progression, functional outcomes and real-world treatment patterns in patients with GA secondary to AMD, including: Encore findings from a time-to-event analysis of driving eligibility maintenance following IZERVAY treatment IZERVAY's impact on hyper transmission progression, an additional GA biomarker Real-world IZERVAY treatment patterns in patients with GA secondary to AMD receiving concomitant anti-VEGF therapy Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma "Geographic atrophy has a substantial impact on patients' daily lives and wellbeing. The data presented at ASRS reflect our steadfast commitment to advancing understanding of the disease and exploring approaches that may address patient needs at different stages of GA. Through IZERVAY, we continue to generate evidence that deepens our understanding of disease progression and patient-relevant outcomes. At the same time, we are pioneering next-generation modalities such as ASP7317, our investigational retinal cell therapy for advanced GA. More broadly, our ambition in ophthalmology is to transform the management of currently irreversible retinal diseases." Astellas Presentations at 2026 ASRS Annual Meeting Podium Presentations On Demand 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. 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 avacincaptad pegol (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 , 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 . 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. SOURCE Astellas Pharma Inc. 21% more press release views with Request a Demo