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

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

US retina specialists' preferences for treating geographic atrophy with gene therapy and complement inhibitors (ARVO 2025) - "Results The final dataset included 166 RS, 25% (n=42) had experience as investigators in GA clinical trials, the majority had utilised complement inhibitors (pegcetacoplan (77%; n=127) and/or avacincaptad pegol (58%; n=97)) and 48% (n=80) owned a private practice...They also preferred a one-time injection over monthly injections and would tolerate some increase in the risk of side effects for this. These insights into provider preferences may inform the development of new treatments that align with what retina specialists believe will best help their GA patients."

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

Structural insights into the mechanism of inhibition of C5 activation by avacincaptad pegol, an aptamer approved for the treatment of geographic atrophy secondary to age-related macular degeneration (ARVO 2025) - "Our studies revealed that ACP blocks the region of C5 involved in its activation. These results provide new knowledge of ACP's action, which can be used to optimize the benefits of ACP use and develop better medicines in the future."

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

Nonclinical pharmacology and pharmacokinetic properties of avacincaptad pegol, an aptamer against C5 approved for the treatment of geographic atrophy secondary to age-related macular degeneration (ARVO 2025) - "We have used various experimental methods to evaluate our FDA-approved drug, avacincaptad pegol, which is designed to treat GA. We found that by carefully designing and interpreting the results of these experiments we can predict the effectiveness of the drugs with high chance of success in patients."

PK/PD data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Utilization Patterns and Adverse Outcomes of Anti-Complement Therapy in Geographic Atrophy in the Clinical Setting (ARVO 2025) - "Methods A retrospective cohort study using Vestrum Health Retina Database including 13,988 eyes treated with pegcetacoplan and 5,720 treated with avacincaptad pegol between February 2023 to September 2024...However, they require regular eye injections and may carry risks like inflammation or infection, which the study highlights. This research provides insights into these treatments' real-world benefits and risks, helping doctors make informed decisions for this condition."

Adverse events • Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

A Review of Early-Stage Clinical Trials for the Treatment of Geographic Atrophy (ARVO 2025) - "In 2023, Syfovre (Apellis) received the first FDA approval for the treatment of GA, followed by Izervay (Iveric). 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 • Review • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Astellas Submits New Drug Application for Conditional Approval of Avacincaptad Pegol for Geographic Atrophy in Japan (PRNewswire) - "Astellas Pharma...today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol intravitreal solution (ACP), a synthetic aptamer that inhibits the complement C5 protein, for the treatment of GA secondary to AMD....The NDA submission is based on results of overseas clinical trials, including the GATHER1 and GATHER2 randomized..."

Japan approval • Age-related Macular Degeneration • Ophthalmology

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy (clinicaltrials.gov) - P=N/A | N=1000 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

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

U.S. FDA Approves Expanded Label for Astellas’ IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy (PRNewswire) - "Astellas Pharma...announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, IZERVAY is now approved without a limitation on duration of dosing-providing physicians and patients with greater flexibility when managing GA. The approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, within days of meeting with the FDA to clarify the Agency's feedback provided in the Complete Response Letter (CRL) issued in November 2024....The approved label update was based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY through year 2."

FDA approval • Age-related Macular Degeneration

U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy (PRNewswire) - "Astellas Pharma...announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025, in response to the Agency's November 2024 Complete Response Letter (CRL). The application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period....The sNDA seeks to add positive 2-year data to the IZERVAY U.S. Prescribing Information based on results from the GATHER2 Phase 3 clinical trial."

FDA filing • Age-related Macular Degeneration

Geographic Atrophy in Age-Related Macular Degeneration. (PubMed, Dtsch Arztebl Int) - "In Europe at present, there is no approved treatment for GA due to AMD. There is thus a continuing need for preventive and rehabilitative measures such as smoking cessation, a balanced diet, and magnifying visual aids for patients in the advanced stages of the disease."

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

Valeda Light Delivery System for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

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

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

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