Eylea (aflibercept) for retinopathy of prematurity

Context 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

Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)

Gestational age

Not reported

Postnatal age

Not reported

Follow-up

Not applicable (regulatory context)

• Effect Guidance Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • Not stated in the source
  • United States (FDA-approved labelling)
  • Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-15

  Next evidence check due

  Not scheduled

  Sources and citations (2)

  1. Supports Eylea prescribing information for BLA125387: openFDA drug label record

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drug label endpoint, fetched on 2026-10-15. The wording is the dataset's copy of the label as of the date fetched, not the current DailyMed label.

     Locator

     results[0].indications_and_usage[0]

     How it applies

     openFDA label record, CC0; label version 41.

     Retrieved

     2026-10-15T13:51:07Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     1ca62da9d61b815e545b5bbf2ee65ea6f4a2c8d605f1b4793097c9bb8cea7890

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-label-BLA125387.json. Short quotations only.

  2. Supports FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection

     Regulator · U.S. Food and Drug Administration · Edition The approval letter PDF fetched on 2026-10-15; its electronic signature page is dated 02/08/2023.

     Locator

     Page 1, paragraph 2

     How it applies

     FDA supplement approval letter; short quotation.

     Retrieved

     2026-10-15T13:51:23Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     98ac3b772aece6e7e4c3f5657e62b880abec367d4e82bc1f45198bb6dba87931

     Reuse basis

     The FDA website policies page (fetched as mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. The PDF bytes are not committed; only the hash is kept. Short quotations only.

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • Not stated in the source
  • United States (FDA-approved labelling)
  • Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-15

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA application BLA125387, EYLEA: openFDA Drugs@FDA record

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda JSON record fetched on 2026-10-15. It gives the application number, sponsor, products, marketing status and the submission history with status dates written YYYYMMDD. · BLA: BLA125387

     Locator

     results[0].submissions[15] (SUPPL 75) and sponsor_name

     How it applies

     openFDA drugsfda JSON, CC0.

     Retrieved

     2026-10-15T13:50:50Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     3c0fbb47eb0994791de2be0d103deab09dc1f343d46efb8555dce1dd76145d2a

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-drugsfda-BLA125387.json.

  2. Supports FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection

     Regulator · U.S. Food and Drug Administration · Edition The approval letter PDF fetched on 2026-10-15; its electronic signature page is dated 02/08/2023.

     Locator

     Page 1: header, paragraph 2 and Approval & Labeling

     How it applies

     FDA supplement approval letter; short quotation.

     Retrieved

     2026-10-15T13:51:23Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     98ac3b772aece6e7e4c3f5657e62b880abec367d4e82bc1f45198bb6dba87931

     Reuse basis

     The FDA website policies page (fetched as mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. The PDF bytes are not committed; only the hash is kept. Short quotations only.

  3. Supports Eylea prescribing information for BLA125387: openFDA drug label record

     Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drug label endpoint, fetched on 2026-10-15. The wording is the dataset's copy of the label as of the date fetched, not the current DailyMed label.

     Locator

     results[0].indications_and_usage[0], version, effective_time

     How it applies

     openFDA label record, CC0; label version 41.

     Retrieved

     2026-10-15T13:51:07Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     1ca62da9d61b815e545b5bbf2ee65ea6f4a2c8d605f1b4793097c9bb8cea7890

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-label-BLA125387.json. Short quotations only.