title: Severe Ocular Inflammation Following Ranibizumab or Aflibercept Injections for Age-Related Macular Degeneration: A Retrospective Claims Database Analysis.
abstract: OBJECTIVE
  Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents including ranibizumab and aflibercept are used to treat patients with ocular disorders such as neovascular age-related macular degeneration (nAMD); however, the injections are associated with rare instances of severe ocular inflammation. This study compared severe ocular inflammation rates in patients treated with ranibizumab versus aflibercept.
  
  
  METHODS
  United States physician-level claims data covering an 18-month period for each therapy were analyzed. The primary analysis compared severe ocular inflammation event rates per 1000 injections. Sensitivity and subgroup analyses evaluated the impact of factors including intraocular surgery, intravitreal antibiotic administration, and previous intravitreal injections.
  
  
  RESULTS
  The analysis included 432,794 injection claims (ranibizumab n = 253,647, aflibercept n = 179,147); significantly, more unique severe ocular inflammation events occurred in patients receiving aflibercept than ranibizumab (1.06/1000 injections, 95% confidence interval [CI], 0.91-1.21, vs. 0.64/1000 injections, 95% CI 0.54-0.74; p < 0.0001). Comparable results were observed for analyses of patients who had undergone glaucoma or cataract surgeries, had antibiotic-associated endophthalmitis, had non-antibiotic-associated endophthalmitis, and were non-treatment-naive. In contrast, no significant differences in severe ocular inflammation claims were recorded in treatment-naive patients who had no record of anti-VEGF treatment in the 6 months preceding the index claim. No significant change occurred in the rate of severe ocular inflammation claims over time following ranibizumab treatment.
  
  
  CONCLUSIONS
  Severe ocular inflammation was more frequent following intravitreal injection with aflibercept than with ranibizumab during routine clinical use in patients with nAMD. This highlights the importance of real-world, post-approval, observational monitoring of novel medicines, and may aid clinical decision-making, including choice of anti-VEGF agent.
authors: a Centre Hospitalier Intercommunal Créteil , Université Paris-Est , Créteil , France.
authors: Eric H
authors: EH
authors: Souied
authors: b Retinal Consultants of Arizona, Phoenix, AZ, USA and USC Eye Institute, Keck School of Medicine , University of Southern California , Los Angeles , CA , USA.
authors: Pravin U
authors: PU
authors: Dugel
authors: c Novartis Pharma AG , Basel , Switzerland.
authors: Alberto
authors: A
authors: Ferreira
authors: c Novartis Pharma AG , Basel , Switzerland.
authors: Ron
authors: R
authors: Hashmonay
authors: d IMS Health , Plymouth Meeting , PA , USA.
authors: Jingsong
authors: J
authors: Lu
authors: e Royal Bolton Hospitals NHS Foundation Trust , Bolton , UK.
authors: Simon P
authors: SP
authors: Kelly
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D016208:Databases, Factual; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D009877:Endophthalmitis / Q000188:drug therapy / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D020408:Health Insurance Portability and Accountability Act / Q000706:statistics & numerical data; D006801:Humans; D007344:Insurance Claim Reporting / Q000706:statistics & numerical data; D007345:Insurance Claim Review / Q000706:statistics & numerical data*; D058449:Intravitreal Injections / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000627:therapeutic use; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D014481:United States; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D057135:Wet Macular Degeneration / Q000188:drug therapy*
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D000069579:Ranibizumab
keywords: Aflibercept; anti-VEGF therapy; claims database; endophthalmitis; intravitreal injection; neovascular age-related macular degeneration