{
 "query": "aflibercept",
 "ingredient": "aflibercept",
 "slug": "aflibercept",
 "rxcui": "1232150",
 "brands": [
  "Eylea"
 ],
 "names": [
  "aflibercept"
 ],
 "classes": [
  {
   "id": "S01LA",
   "name": "Antineovascularisation agents"
  }
 ],
 "alternatives": [
  "bevacizumab",
  "brolucizumab",
  "faricimab",
  "pegaptanib",
  "ranibizumab",
  "verteporfin"
 ],
 "label": {
  "route_mode": "INTRAVITREAL",
  "route_counts": {
   "INTRAVITREAL": 3,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)",
  "contraindications": "Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity EYLEA HD is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA HD. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation.",
  "warnings_and_cautions": "Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ( 5.3 ) 5.1 Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion Intravitreal injections including those with aflibercept have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] and, more rarely, retinal vasculitis with or without occlusion [see Adverse Reactions (6.2) ] . Proper aseptic injection technique must always be used when administering EYLEA HD. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately [see Dosage and Administration ...",
  "warnings": "",
  "adverse_reactions": "The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (\u22653%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 1755 patients were treated with EYLEA HD and...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.4 ) 11/2025 Dosage and Administration ( 2.2 , 2.3 , 2.4 ) 4/2026 Dosage and Administration ( 2.5 ) 11/2025 Warnings and Precautions ( 5.3 ) 4/2026",
  "information_for_patients": "In the days following EYLEA HD administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients and/or caregivers to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1) ] . Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations [see Adverse Reactions (6.1) ] . Advise patients not to drive or use machinery until visual function has recovered sufficiently.",
  "spl_medguide": "",
  "clinical_studies": "14.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The safety and efficacy of EYLEA HD were assessed in a randomized, multi-center, double-masked, active-controlled study (PULSAR) in treatment-na\u00efve patients with nAMD. A total of 1009 patients were treated and analyzed for efficacy (673 with EYLEA HD). Patients were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: 1) EYLEA HD administered every 12 weeks following 3 initial monthly doses (HDq12); 2) EYLEA HD administered every 16 weeks following 3 initial monthly doses (HDq16); 3) EYLEA 2 mg administered every 8 weeks (2q8) following 3 initial monthly doses. In the EYLEA HD groups, patients could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria, starting at week 16. Starting at week 52, patient dosing intervals could be extended by 4-week increments if all protocol-defined visual and anatomic criteria were met at visits in Year 2 (i.e., BCVA loss <5 letters from Week 12, no fluid in the central subfield on OCT, and no new onset foveal hemorrhage or foveal neovascularization). Patients ranged from 50 to 96 years of age with a mean of 74.5 years. At baseline, me...",
  "brand_name": "EYLEA HD",
  "manufacturer": "Regeneron Pharmaceuticals, Inc",
  "application_number": "BLA761355",
  "pharm_class_epc": [
   "Vascular Endothelial Growth Factor Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVITREAL"
  ],
  "effective_time": "20260406",
  "set_id": "86d8848b-111b-4da9-8957-7cccef1b8f66",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 30073,
  "serious": 24293,
  "death": 8659,
  "hospitalization": 3661,
  "primary_suspect": 30066,
  "top_reactions": [
   [
    "Death",
    7748
   ],
   [
    "Visual Impairment",
    2099
   ],
   [
    "Off Label Use",
    1645
   ],
   [
    "Blindness",
    1456
   ],
   [
    "Endophthalmitis",
    1370
   ],
   [
    "Visual Acuity Reduced",
    1201
   ],
   [
    "Eye Pain",
    1196
   ],
   [
    "Drug Ineffective",
    1192
   ],
   [
    "Vision Blurred",
    1183
   ],
   [
    "Product Dose Omission Issue",
    1136
   ],
   [
    "Blindness Unilateral",
    1079
   ],
   [
    "Blindness Transient",
    1018
   ],
   [
    "Eye Inflammation",
    981
   ],
   [
    "Eye Haemorrhage",
    798
   ],
   [
    "Vitreous Floaters",
    794
   ]
  ],
  "by_year": {
   "2019": 4431,
   "2020": 3545,
   "2021": 1921,
   "2022": 1690,
   "2023": 1495,
   "2024": 2563,
   "2025": 1621,
   "2026": 1121
  },
  "by_year_primary": {
   "2019": 4431,
   "2020": 3545,
   "2021": 1921,
   "2022": 1688,
   "2023": 1495,
   "2024": 2559,
   "2025": 1620,
   "2026": 1121
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240515",
   "reason": "Lack of Assurance of Sterility: Complaints of syringe breakage",
   "firm": "Regeneron Pharmaceuticals Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20240423",
   "reason": "Lack of Assurance of Sterility: Complaints of syringe breakage",
   "firm": "Regeneron Pharmaceuticals Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 2,
  "nda": 0,
  "anda": 0,
  "first_approval": "20111118",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "REGENERON PHARMACEUTICALS"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/18/2011"
 },
 "trials": {
  "total": 613,
  "completed": 373,
  "terminated": 72,
  "with_results": 185,
  "industry": 388,
  "phase3": 138,
  "results_share": 0.4959785522788204,
  "terminated_share": 0.11745513866231648
 },
 "pubmed": {
  "rct": 219,
  "meta": 48,
  "recent_rct": 96,
  "cochrane": [
   {
    "pmid": "26857947",
    "title": "Aflibercept for neovascular age-related macular degeneration",
    "year": "2016"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 415586.11,
  "records": 2419,
  "by_name": [
   [
    "Eylea",
    415586.11
   ]
  ],
  "names_checked": [
   "aflibercept",
   "Eylea"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 32770,
  "beneficiaries": 8375,
  "spend": 82833701.38,
  "by_brand": [
   {
    "brand": "Eylea",
    "claims": 29232,
    "per_claim": 2433.8018377,
    "is_generic": false
   },
   {
    "brand": "Eylea Hd",
    "claims": 3538,
    "per_claim": 3303.7891634,
    "is_generic": false
   }
  ],
  "per_claim": 2527.7296728715287
 },
 "mdl": [
  {
   "number": "3103",
   "title": "Aflibercept Patent Litigation",
   "judge": "Kleeh, Thomas S.",
   "court": "WVN",
   "docket": "1:24-md-3103",
   "actions": "",
   "matched": "aflibercept"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "Death appears in 3.2x the share of reports seen across all of FAERS (-12)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "219 randomized trials and 48 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 50% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III (-6)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 45,
   "letter": "F",
   "why": [
    "Pharma paid doctors $415,586 tied to this drug last year (-15)",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, visual impairment, blindness. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over bevacizumab, brolucizumab, faricimab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}