# Aflibercept

Drug · id `maternal:aflibercept` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

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Browse, life stage: Newborn; Infant follow-up  
Browse, care area: Preterm and sick newborns  

## In plain language

A medicine injected into the eye that blocks VEGF, a protein that drives the growth of blood vessels. It is used for several eye diseases, including, in the United States since 2023, retinopathy of prematurity. In the FIREFLEYE trial it did not meet the rule for matching laser treatment.

## Technical summary

Drug, level substance. RxCUI 1232150 (RxNav name aflibercept, term type IN) read 2026-10-15. The Eylea label calls Eylea a vascular endothelial growth factor (VEGF) inhibitor. The one claim on this page is FIREFLEYE (a noninferiority trial of aflibercept against laser, whose result did not meet the criteria), with the label's listing of ROP given as context; it is an evaluated-for link, not a treats link. The ROP approval and the treats link are on the Eylea ROP page.

## Claims, with the population each applies to

## Context: Infants with retinopathy of prematurity needing treatment (FIREFLEYE trial)

Recipient: Newborn; Population: 118 infants were randomised: gestational age 32 weeks or less at birth or birth weight 1500 g or less, with ROP of specified severity (zone I stage 1+, 2+, 3 or 3+, or zone II stage 2+ or 3+) needing treatment, or with aggressive posterior ROP, in at least one eye. 113 were treated and 104 completed the study. They were enrolled between September 25, 2019, and August 28, 2020, at 64 hospital sites in 27 countries across Asia, Europe and South America.; Care setting: 64 hospital sites in 27 countries throughout Asia, Europe and South America; Geography: 27 countries across Asia, Europe and South America (the abstract names none); Life stage: Infants with retinopathy of prematurity requiring treatment, with 24 weeks of follow-up; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: The primary outcome was treatment success 24 weeks after starting treatment: no active ROP and no unfavourable structural outcomes, assessed by investigators; the need for rescue treatment counted as treatment failure.

### In FIREFLEYE, infants with retinopathy of prematurity needing treatment were randomised 2:1 to a 0.4-mg dose of intravitreal aflibercept (75 infants) or laser photocoagulation (43 infants randomised, 38 treated). Treatment success at 24 weeks was 85.5% with aflibercept and 82.1% with laser (between-group difference 3.4%; 1-sided 95% credible interval, -8.0% to infinity). Aflibercept was to be judged noninferior if the lower limit of that interval was above -5%; the authors report that it did not meet the criteria for noninferiority. Rescue treatment was needed in 4.8% of eyes in the aflibercept group and 11.1% in the laser group. Serious adverse events were 13.3% (ocular) and 24.0% (systemic) with aflibercept and 7.9% and 36.8% with laser. Three deaths, 4 to 9 weeks after aflibercept treatment, were considered unrelated to aflibercept by the investigators. The authors say further data are needed for more definitive conclusions. Separately, the US Eylea label lists retinopathy of prematurity among its five indications.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Newborn; Population: 118 infants were randomised: gestational age 32 weeks or less at birth or birth weight 1500 g or less, with ROP of specified severity (zone I stage 1+, 2+, 3 or 3+, or zone II stage 2+ or 3+) needing treatment, or with aggressive posterior ROP, in at least one eye. 113 were treated and 104 completed the study. They were enrolled between September 25, 2019, and August 28, 2020, at 64 hospital sites in 27 countries across Asia, Europe and South America.; Care setting: 64 hospital sites in 27 countries throughout Asia, Europe and South America; Geography: 27 countries across Asia, Europe and South America (the abstract names none); Life stage: Infants with retinopathy of prematurity requiring treatment, with 24 weeks of follow-up; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: The primary outcome was treatment success 24 weeks after starting treatment: no active ROP and no unfavourable structural outcomes, assessed by investigators; the need for rescue treatment counted as treatment failure.
- Limitations: Only the abstract was read. The abstract does not state whether the trial was masked; its primary outcome was assessed by investigators at 24 weeks. Noninferiority was not shown, so this record does not say aflibercept works as well as laser. The label lists the indication; the abstract and the label are separate sources, and the label wording does not rest on this trial in anything read here.
- Last checked: 2026-10-15
- Sources:
  1. Supports: Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2022.10564>
     Locator: Abstract, RESULTS sentences 3 to 6 and CONCLUSIONS AND RELEVANCE. Retrieved 2026-10-15T13:49:23Z. Source state: Current. Snapshot hash: cc9f28da5292d3e890c048e260579f8628ef364cf742dafd6d12c8ee06b5274a.
     How it applies: Treatment success, rescue treatment, adverse events, deaths and the authors' conclusion.
  2. Background: Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2022.10564>
     Locator: Abstract, OBJECTIVE, DESIGN, INTERVENTIONS and MAIN OUTCOMES. Retrieved 2026-10-15T13:49:23Z. Source state: Current. Snapshot hash: cc9f28da5292d3e890c048e260579f8628ef364cf742dafd6d12c8ee06b5274a.
     How it applies: Population, groups, outcome and noninferiority rule.
  3. Background: 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.) <https://api.fda.gov/drug/label.json?search=openfda.application_number:%22BLA125387%22>
     Locator: results\[0\].indications\_and\_usage\[0\]. Retrieved 2026-10-15T13:51:07Z. Source state: Current. Snapshot hash: 1ca62da9d61b815e545b5bbf2ee65ea6f4a2c8d605f1b4793097c9bb8cea7890.
     How it applies: Label lists ROP among five indications; openFDA label CC0.

## Connected pages

- FIREFLEYE: aflibercept compared with laser in infants with ROP needing treatment: Retinopathy of prematurity (`maternal:retinopathy-of-prematurity`) [a claim, not a settled fact; see claim `maternal:claim-aflibercept-fireflye-rop` and its context]
- Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`)
- Contained in: Eylea (aflibercept) for retinopathy of prematurity (`maternal:eylea-rop`)

## Provenance

Content hash: a2d59e15bba670d1f3081c626c25f26b92a0a85f273063b41b37d7ea7af2277c
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15