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aflibercept

Sold as Eylea. Class: Antineovascularisation agents. First FDA approval 11/18/2011: 15 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (73/100)

Safety ×35%
B
Evidence ×25%
C
Regulatory ×15%
A
Money & lawsuits ×15%
F
Options ×10%
C

Safety: 83

Evidence: 68

Regulatory history: 89

Money & lawsuits: 45

Options: 70

What the FDA label says

Approved uses

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 precautions

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 ...

Adverse reactions (label)

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 (≥3%) 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...

Recent major label 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

Source: FDA SPL label for EYLEA HD (Regeneron Pharmaceuticals, Inc), effective 20260406. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

30,073reports that mention this drug
30,066of those blame this drug, not another one the person was taking
81%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
28.8%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Death · 7,748Visual Impairment · 2,099Off Label Use · 1,645Blindness · 1,456Endophthalmitis · 1,370Visual Acuity Reduced · 1,201Eye Pain · 1,196Drug Ineffective · 1,192Vision Blurred · 1,183Product Dose Omission Issue · 1,136Blindness Unilateral · 1,079Blindness Transient · 1,018Eye Inflammation · 981Eye Haemorrhage · 798Vitreous Floaters · 794

Reports per year

20192020202120222023202420252026
4,4313,5451,9211,6901,4952,5631,6211,121

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

2recall actions on file
0 / 0brand / generic applications
0label changes since 2021
NoREMS program
DateClassFirmReason
05/2024Class IIRegeneron Pharmaceuticals IncLack of Assurance of Sterility: Complaints of syringe breakage
04/2024Class IIRegeneron Pharmaceuticals IncLack of Assurance of Sterility: Complaints of syringe breakage

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

219randomized trials (PubMed)
48systematic reviews
613registered trials
50%of completed trials posted results
12%terminated or withdrawn
63%industry-funded

Independent Cochrane reviews

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $415,586 in payments to US physicians and hospitals tied to this drug across 2,419 transactions (Eylea $415,586).

Pending federal multidistrict litigation

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

8,375Medicare Part D patients (2024)
32,770prescriptions filled
$2,528average cost per fill
$83Mtotal Medicare spend
ProductFills$/fill
Eylea29,232$2,434
Eylea Hd3,538$3,304

Same-class alternatives

2 drugs in the same class grade a letter or more higher than aflibercept on this site. Worth asking whether one of them would do the same job for you.

brolucizumabpegaptanibverteporfin

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are death, visual impairment, blindness. How would we recognize and handle those?
  2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  3. Why this one over bevacizumab, brolucizumab, faricimab? What would make you pick one of those instead?
  4. There is no generic. Is there an older generic in the same class that works as well for my situation?
  5. This drug is in active federal litigation. What is the claim, and does it affect my risk?
  6. What result are we expecting, by when, and what is the plan if it does not happen?
  7. 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.)