{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:eylea-rop",
  "owner": "maternal",
  "kind": "product",
  "slug": "eylea-rop",
  "name": "Eylea (aflibercept) for retinopathy of prematurity",
  "aliases": [
    "Eylea",
    "EYLEA"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "Eylea is an injection into the eye, made by Regeneron, that FDA approved in 2023 for a new use: treating retinopathy of prematurity. Retinopathy of prematurity is one of five conditions on the Eylea label. The FIREFLEYE trial compared an aflibercept injection with laser treatment in babies with the disease; aflibercept did not meet the trial's rule for matching laser.",
  "summary_technical": "Product, medicine. openFDA lists BLA125387 (sponsor REGENERON PHARMACEUTICALS) with supplement 75, an efficacy supplement, dated 2023-02-08; the FDA approval letter for BLA 125387/S-075 says the supplement adds a new indication for treatment of retinopathy of prematurity. Product: EYLEA injection, 40MG/ML aflibercept, route intravitreal. Label read: openFDA label version 41, effective 2026-07-07. This record covers the ROP use only; the other four labelled uses are not recorded.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn",
        "infant-follow-up"
      ],
      "care-area": [
        "preterm-and-sick-newborn"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "EYLEA injection, aflibercept 40MG/ML (Drugs@FDA), intravitreal route (openFDA label)",
    "version": "openFDA label version 41, effective 2026-07-07; ROP indication added by supplement S-075 (approval letter dated 2023-02-08)",
    "intended_use_snapshots": [
      "maternal:openfda-label-bla125387-2026-10-15",
      "maternal:fda-bla125387-s075-letter-2026-10-15"
    ]
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
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  "claims": [
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      "release_id": "fc5a600ec7387e71",
      "id": "maternal:claim-eylea-label-rop-indication",
      "owner": "maternal",
      "subject_entity_id": "maternal:eylea-rop",
      "category": "effect",
      "statement": "The US label for Eylea lists treatment of retinopathy of prematurity among its indications, and the FDA approval letter for supplement S-075 says the supplement provides for the addition of that indication.",
      "context": {
        "id": "maternal:ctx-fda-bla125387-rop-us",
        "label": "Patients with retinopathy of prematurity, US label for Eylea (BLA125387, supplement S-075)",
        "recipient": "newborn",
        "population": "Patients with retinopathy of prematurity (ROP). ROP is one of five conditions the US label lists for treatment with Eylea: neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy and ROP. The indication list read gives no age or gestational limit for ROP; the label's dosing and clinical studies sections were not read.",
        "care_setting": "Not stated in the source",
        "geography": "United States (FDA-approved labelling)",
        "life_stage_note": "Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)",
        "life_stage_terms": {
          "maternal": [
            "newborn",
            "infant-follow-up"
          ]
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        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
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        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory context)",
        "eligibility": {
          "inclusion": [
            "Patients with retinopathy of prematurity"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "guidance",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "This is a regulatory statement: the label's indication list and the approval letter, not a trial result. The label's dosing and clinical studies sections were not read, so no outcome figure is recorded. FIREFLEYE, the trial abstract read for this atlas, did not meet its noninferiority criteria against laser; that result is a separate claim on the aflibercept page and does not support this one. Approval is not a recommendation for any baby.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
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            "title": "Eylea prescribing information for BLA125387: openFDA drug label record",
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          "locator": "Page 1, paragraph 2",
          "applicability_note": "FDA supplement approval letter; short quotation.",
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            "id": "maternal:fda-bla125387-s075-letter",
            "source_type": "regulator",
            "title": "FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection",
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    {
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      "id": "maternal:claim-fda-bla125387-s075-eylea-rop",
      "owner": "maternal",
      "subject_entity_id": "maternal:eylea-rop",
      "category": "regulatory",
      "statement": "FDA approved supplement S-075 to BLA125387 for Eylea (aflibercept) Injection on 2023-02-08; the approval letter says the supplement provides for the addition of a new indication for treatment of retinopathy of prematurity. openFDA lists the supplement as submission type SUPPL, number 75, class Efficacy, sponsor REGENERON PHARMACEUTICALS. The US label (openFDA copy, version 41, effective 2026-07-07) says Eylea is indicated for the treatment of patients with five conditions: neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy and retinopathy of prematurity.",
      "context": {
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        "label": "Patients with retinopathy of prematurity, US label for Eylea (BLA125387, supplement S-075)",
        "recipient": "newborn",
        "population": "Patients with retinopathy of prematurity (ROP). ROP is one of five conditions the US label lists for treatment with Eylea: neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy and ROP. The indication list read gives no age or gestational limit for ROP; the label's dosing and clinical studies sections were not read.",
        "care_setting": "Not stated in the source",
        "geography": "United States (FDA-approved labelling)",
        "life_stage_note": "Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)",
        "life_stage_terms": {
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        "followup_description": "Not applicable (regulatory context)",
        "eligibility": {
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      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
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      "limitations": "Approval means FDA found the product acceptable for the labelled use in the United States; it is not a recommendation for any baby. ROP is one of five labelled uses, and this record covers only the ROP indication. The current label wording is from the openFDA copy and was not compared with the DailyMed page. The decision date is the openFDA submission status date, which equals the date of the electronic signature on the approval letter. The label's dosing and clinical studies sections for ROP were not read. FIREFLEYE's finding that aflibercept did not meet noninferiority against laser is a separate claim on the aflibercept page.",
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      "indication": "Treatment of retinopathy of prematurity (ROP): the approval letter says supplement S-075 provides for the addition of a new indication for treatment of ROP. On the current label ROP is one of five indications, each listed as treatment of patients with the condition; the indication list read gives no age or gestational limit for ROP.",
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