Izervay (avacincaptad pegol intravitreal solution) / Astellas - LARVOL DELTA

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Astellas Pharma Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Aptamers as therapeutic targets: prospects and progress in the treatment of cancers. (PubMed, Nucleosides Nucleotides Nucleic Acids) - "Pegaptanib and Izervay are the approved aptamers against age-related macular degeneration (AMD) that target vascular endothelial growth factor (VEGF) and block complement component protein C5, respectively...Aptamosomes, encapsulating drugs like doxorubicin, effectively reduce tumour size and are highly advantageous over targeted drug delivery...It also outlines the roles of aptamers and connects their modes of action with specific cancer types. The content is highly detailed, providing a comprehensive understanding of aptamer therapy and its applications."

Journal • Review • Age-related Macular Degeneration • Hematological Malignancies • Leukemia • Macular Degeneration • Oncology • Ophthalmology • Retinal Disorders • AXL • EGFR • MUC1 • SPP1 • VIM

Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1) (clinicaltrials.gov) - P2 | N=121 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Inherited Retinal Dystrophy • Macular Degeneration • Ophthalmology • Retinal Disorders

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Silicone oil microdroplets from syringes with intravitreal anti-vascular endothelial growth factor and complement inhibitor injections. (PubMed, Retina) - "Commonly used BD polycarbonate syringes for intravitreal injections caused significantly higher levels of silicone oil to be injected into the eye than prefilled or silicone free syringes. Repeated injections with more viscous intravitreal drugs increase the amount of silicone oil in the vitreous, leading to symptomatic floaters."

Journal

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P1 | N=132 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy (clinicaltrials.gov) - P3 | N=278 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Innovative technologies for the treatment of dry age-related macular degeneration (AMD) - modern therapeutic perspectives and their future. (PubMed, Rom J Ophthalmol) - "Advances include molecularly targeted therapies (Pegcetacoplan, Avacincaptad Pegol) that reduce inflammation, gene therapy (HMR59) protecting RPE cells, and mitochondria-targeted drugs (SS-31) mitigating oxidative stress...However, further clinical trials are needed to optimize these strategies, assess long-term outcomes, and expand patient access to effective treatments. These advancements have the potential to significantly improve the quality of life for individuals affected by dry AMD."

Journal • Review • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Gene Therapies • Infectious Disease • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Transplantation

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=20 | Not yet recruiting | Sponsor: Astellas Pharma Inc

New P3 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Astellas to Present New Data in Geographic Atrophy at Upcoming Ophthalmology Annual Congresses (PRNewswire) - "Research highlights include: An oral presentation on the structure-function relationship between baseline central subfield ellipsoid zone (EZ) integrity and visual acuity at baseline and future vision loss; An oral presentation on baseline EZ integrity features linked to GA progression in eyes with differential shifts in GA growth rate; Multiple posters evaluating imaging data from the GATHER1 and GATHER2 studies, which link structure and function in GA; Two preclinical posters with structural insights refining the mechanism of action, as well as pharmacokinetics and pharmacodynamics, of avacincaptad pegol (ACP); Data from qualitative studies assessing the experience of patients with GA in the U.S., Spain, Germany and France, including the impact of disease symptoms on health-related quality of life (HRQoL) and coping mechanisms used to manage symptoms of GA."

Clinical data • Preclinical • Age-related Macular Degeneration • Ophthalmology

Ocular Adverse Events Associated with Pegcetacoplan and Avacincaptad Pegol for Geographic Atrophy: A Population-Based Pharmacovigilance Study: Ocular Adverse Events of Pegcetacoplan & Avacincaptad Pegol. (PubMed, Am J Ophthalmol) - "Based on current prescribing patterns, a broader spectrum of ocular AEs were reported for pegcetacoplan than avacincaptad pegol. These findings aim to enhance clinicians' understanding of the safety profiles of these agents, enabling informed patient care and heightened vigilance of these novel GA treatments."

Adverse events • Journal • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis

Clinical Outcomes of Treatment of Geographic Atrophy: A Narrative Review. (PubMed, Ophthalmol Ther) - "The management of geographic atrophy has advanced with therapies like pegcetacoplan and avacincaptad pegol showing clear benefits in slowing lesion growth. However, safety concerns, such as neovascular complications, persist. Photobiomodulation and dietary supplementation provide alternative options with modest benefits, particularly in the early stages. Larger studies are needed to confirm long-term safety, efficacy, and optimal treatment strategies."

Clinical data • Journal • Review • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Real-World Outcomes with Complement Inhibitors for Geographic Atrophy: A Comparative Study of Pegacetacoplan versus Avacincaptad Pegol. (PubMed, Clin Ophthalmol) - "This real-world study reports that treatment with IVA and IVP have similar visual and anatomic outcomes at 12-months, although subjects undergoing treatment with IVP may receive fewer injections to obtain these outcomes. Further studies comparing the safety and efficacy of IVA and IVP are warranted."

Journal • Real-world evidence • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Syfovre and Izervay Clinical Outcomes (ARVO 2025) - "One eye developed RV confirmed by angiography and was treated with prednisone, difluprednate, and pressure-lowering drops; at month 2, logMAR VA plateaued at 1.3 from 0.47. One eye underwent RD repair following IVS and IV faricimab...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Clinical data • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

The 20th Anniversary of Pegaptanib (MacugenTM), the First Approved Aptamer Medicine: History, Recent Advances and Future Prospects of Aptamers in Therapy. (PubMed, Pharmaceutics) - "Despite their high potential, only two aptamers have been approved to date, pegaptanib (MacugenTM) and avacincaptad pegol (IzervayTM), both for the treatment of age-related macular degeneration (AMD). We describe its chemistry and track its development from the earliest stages to the preclinical phase, clinical trials, and eventual regulatory approval. Additionally, we evaluate its position among other therapeutic agents and provide a comprehensive overview of pegaptanib's efficacy, safety, and cost-effectiveness, comparing these aspects with those of monoclonal antibodies with similar indications, bevacizumab and ranibizumab."

Journal • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Performance of ChatGPT in Diagnosing, Assessing, and Managing Retinal Eye Diseases (ARVO 2025) - "However, its management strategies failed to include newer or recently approved treatments such as farcimab-svoa, avacincaptad pegol, and biosimilars...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ocular Inflammation • Ophthalmology • Retinal Disorders

Fundus Hyperautofluorescence and Autofluorescence Changes in Patients Following a Single Dose of AVD-104 for the Treatment of Geographic Atrophy Secondary to Age-related Macular Degeneration in the SIGLEC Phase 2a Study (ARVO 2025) - "The ongoing Phase 2b/3 SIGLEC study assessing AVD-104 in a head-to-head fashion against avacincaptad pegol in 300 patients with GA secondary to AMD is fully enrolled. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2a data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Association of baseline central subfield ellipsoid zone integrity with baseline visual acuity and future vision loss in the GATHER clinical trials (ARVO 2025) - "Methods GATHER1 (18-month phase 2/3 trial) and GATHER2 (2-year phase 3 trial) were multicenter, randomized, double-masked, sham-controlled trials that enrolled patients with non-center point involving GA and evaluated the efficacy and safety of avacincaptad pegol 2mg...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology • Retinal Disorders

Complement Inhibition Treatment for Geographic Atrophy in Eyes with Exudative AMD (ARVO 2025) - "Methods A retrospective chart review was performed of eyes treated for GA with either intravitreal pegcetacoplan (Syfovre; Apellis; Waltham, MA) or avacincaptad pegol (Izervay; Astellas; Northbrook, IL) injections. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Real-world safety and efficacy of intravitreal avacincaptad pegol in the treatment of fovea threatening geographic atrophy due to age-related macular degeneration. (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety of Avacincaptad Pegol for Geographic Atrophy: Real-world experience. (ARVO 2025) - "These findings suggest that avacincaptad pegol is generally safe for managing GA, providing hope for patients with this challenging condition. However, we recommend careful monitoring during treatment to manage potential side effects effectively."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Structure-function link between ellipsoid zone integrity features and visual acuity in eyes with geographic atrophy in the GATHER1 and GATHER2 clinical trials (ARVO 2025) - "Methods GATHER1 (phase 2/3) and GATHER2 (phase 3) were multicenter, randomized, double-masked, sham-controlled trials in patients with non-center point involving GA that evaluated efficacy and safety of avacincaptad pegol (ACP) 2mg...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

Ellipsoid zone integrity features linked to differential shifts in geographic atrophy growth rate in the GATHER1 and GATHER2 clinical trials (ARVO 2025) - "Methods GATHER1 and GATHER2 were multicenter, randomized, double-masked, sham-controlled trials in patients with non-center point involving GA and evaluated the efficacy and safety of avacincaptad pegol 2mg...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

Association of ellipsoid zone integrity features with diffuse trickling fundus autofluorescence patterns in the GATHER 1/GATHER 2 clinical trials (ARVO 2025) - "Methods GATHER1 (phase 2/3) and GATHER2 (phase 3) trials evaluated the efficacy and safety of avacincaptad pegol (ACP) 2mg in patients with GA...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

iRORA phenotype characterization using fundus autofluorescence: GATHER2 post-hoc analysis for geographic atrophy secondary to AMD (ARVO 2025) - P3 | "Methods In this post-hoc analysis of the GATHER2 trial (NCT04435366, avacincaptad pegol vs sham for GA), pooled eyes were analyzed for presence of baseline iRORA lesions beyond the borders of GA, and each iRORA was assessed for progression to cRORA at 6, 12, and 18 months using OCT...Researchers grouped changes in the FAF images for each lesion as "no change," "increased," "questionably decreased," or "definitely decreased." This is the first report to show how changes in FAF images can identify conversion from incomplete to complete lesions in people with geographic atrophy. This information may assist doctors in grouping lesions using FAF imaging and to better determine the timing of early treatment for eye lesions using different types of imaging, such as FAF."

Retrospective data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders