{
  "abstract": "Background To evaluate the efficacy and safety of aflibercept biosimilars compared with reference aflibercept in the treatment of neovascular age-related macular degeneration (nAMD).Methods A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and registered on PROSPERO (CRD4201069147). Phase 3 randomised controlled trials (RCTs) comparing aflibercept biosimilars to reference aflibercept in treatment-naïve nAMD were included. All included studies employed a standardised on-label aflibercept dosing regimen consisting of three initial monthly loading doses followed by injections every 8 weeks. The primary outcome was the mean difference (MD) in best-corrected visual acuity (BCVA) at week 8. Secondary outcomes included BCVA at week 52, proportion of patients gaining ≥15 letters or maintaining vision (<15-letter loss), central subfield thickness (CST) and adverse events (AEs).Results Six RCTs (2022–2024) were included, comprising 2029 eyes (1020 biosimilar; 1009 reference). BCVA at week 8 did not differ significantly between groups (MD –0.34 letters; 95% CI –1.12 to 0.44; I²=0%; p=0.39), as was BCVA at week 52 (MD –0.04; 95% CI –1.18 to 1.10; I²=1%; p=0.94). No differences were observed in the proportion of patients gaining ≥15 letters, maintaining vision, CST changes or AEs.Conclusions Aflibercept biosimilars demonstrated no significant difference in efficacy at 8 weeks and 52 weeks as well as safety relative to reference aflibercept in eyes with treatment-naïve nAMD following an on-label aflibercept treatment protocol; however, real-world extended durability remains untested. These findings were supported by a low risk of bias and a high-certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations tool.",
  "authors": [
    {
      "affiliations": [
        "Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA"
      ],
      "name": "Charles Zhang"
    },
    {
      "affiliations": [
        "Miller School of Medicine, University of Miami, Miami, Florida, USA"
      ],
      "name": "Neel R Sonik"
    },
    {
      "affiliations": [
        "Miller School of Medicine, University of Miami, Miami, Florida, USA"
      ],
      "name": "Mohammad Ayoubi"
    },
    {
      "affiliations": [
        "Miller School of Medicine, University of Miami, Miami, Florida, USA"
      ],
      "name": "Georges AbouKasm"
    },
    {
      "affiliations": [
        "Northwell Health Eye Institute, Great Heck, New York, USA",
        "Department of Ophthalmology, Manhattan Eye Ear and Throat Hospital, New York, NY, USA"
      ],
      "name": "Daniel Zhu"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA"
      ],
      "name": "Jason C Fan"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA"
      ],
      "name": "Thomas A Albini"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA"
      ],
      "name": "Nicolas A Yannuzzi"
    }
  ],
  "title": "Clinical efficacy and safety of aflibercept biosimilars in neovascular age-related macular degeneration: a systematic review and meta-analysis of randomised controlled trials",
  "uid": "a05082e5-1f1e-57d0-a2f3-0bd71ad2d4c6"
}