# Eylea (aflibercept) for retinopathy of prematurity Product · id `maternal:eylea-rop` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Eylea; EYLEA Browse, life stage: Newborn; Infant follow-up Browse, care area: Preterm and sick newborns ## In plain language 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. ## Technical summary 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. ## Claims, with the population each applies to ## 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) ### 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. - Category: Effect - Evidence stage: Guidance - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: Eylea prescribing information for BLA125387: openFDA drug label record (Regulator, 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\[0\]. Retrieved 2026-10-15T13:51:07Z. Source state: Current. Snapshot hash: 1ca62da9d61b815e545b5bbf2ee65ea6f4a2c8d605f1b4793097c9bb8cea7890. How it applies: openFDA label record, CC0; label version 41. 2. Supports: FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection (Regulator, edition The approval letter PDF fetched on 2026-10-15; its electronic signature page is dated 02/08/2023.) Locator: Page 1, paragraph 2. Retrieved 2026-10-15T13:51:23Z. Source state: Current. Snapshot hash: 98ac3b772aece6e7e4c3f5657e62b880abec367d4e82bc1f45198bb6dba87931. How it applies: FDA supplement approval letter; short quotation. ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: FDA application BLA125387, EYLEA: openFDA Drugs@FDA record (Regulator, 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.) Locator: results\[0\].submissions\[15\] (SUPPL 75) and sponsor\_name. Retrieved 2026-10-15T13:50:50Z. Source state: Current. Snapshot hash: 3c0fbb47eb0994791de2be0d103deab09dc1f343d46efb8555dce1dd76145d2a. How it applies: openFDA drugsfda JSON, CC0. 2. Supports: FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection (Regulator, 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. Retrieved 2026-10-15T13:51:23Z. Source state: Current. Snapshot hash: 98ac3b772aece6e7e4c3f5657e62b880abec367d4e82bc1f45198bb6dba87931. How it applies: FDA supplement approval letter; short quotation. 3. Supports: Eylea prescribing information for BLA125387: openFDA drug label record (Regulator, 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. Retrieved 2026-10-15T13:51:07Z. Source state: Current. Snapshot hash: 1ca62da9d61b815e545b5bbf2ee65ea6f4a2c8d605f1b4793097c9bb8cea7890. How it applies: openFDA label record, CC0; label version 41. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-bla125387-s075` - Product: Eylea (aflibercept) for retinopathy of prematurity (`maternal:eylea-rop`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Supplemental approval, 2023-02-08 - Product version: Eylea (aflibercept) injection, supplement S-075 to BLA125387 (new indication: retinopathy of prematurity); labelling read is openFDA label version 41, effective 2026-07-07 - Pathway: BLA - Submission: BLA125387 - 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. - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-bla125387-s075-eylea-rop` ## Connected pages - Active ingredient (generic name on the label): Aflibercept (`maternal:aflibercept`) - US label and FDA approval: treatment of retinopathy of prematurity: Retinopathy of prematurity (`maternal:retinopathy-of-prematurity`) [a claim, not a settled fact; see claim `maternal:claim-eylea-label-rop-indication` and its context] - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) ## Provenance Content hash: 10e280c850023826da35367c357d2673934a29cd8387001eb1c0ea44b1c28d6d Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15