EYLEA® (aflibercept) Injection Dosing in Wet AMD

Start With EYLEA. Stay With EYLEA.¹

TRUST ≈8 YEARS OF EXTENSIVE CLINICAL EXPERIENCE AND THE INTEGRITY OF DATA FROM LARGE, WELL–CONTROLLED TRIALS¹

EYLEA is the #1 prescribed anti–VEGF FDA approved for Wet AMD, DME, and MEfRVO*

*IBM Truven MarketScan data: Number of injections administered from Q4 2017 through Q3 2018; data on file.

The Established Experience of EYLEA^1,2

≈8 years of real–world experience¹
An estimated ≈9 million doses administered to ≈790,000 eyes since launch (and counting)^1,2
8 phase 3 clinical trials including more than 3000 EYLEA–treated patients across all approved indications¹

Dosing Flexibility in Wet AMD: EYLEA Offers 3 Approved Dosing Intervals¹

EYLEA 2 mg (0.05 mL) Dosing Schedule¹

EYLEA dosing for Wet AMD. Initial dosing 2 mg every 4 weeks x 3 injections. Follow-up dosing options of either 2 mg every 8 weeks or 2 mg every 4 weeks. After one year of effective therapy 2 mg every 12 weeks.

Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (≈ every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every–4–week (monthly) dosing after the first 12 weeks (3 months).

Although not as effective as the recommended every–8–week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.

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Important Safety Information

CONTRAINDICATIONS

EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

WARNINGS AND PRECAUTIONS

Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

ADVERSE REACTIONS

Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

INDICATIONS

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

Please see the full Prescribing Information for EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

Wet AMD: Dosing Flexibility

Start With EYLEA. Stay With EYLEA.¹

TRUST ≈8 YEARS OF EXTENSIVE CLINICAL EXPERIENCE AND THE INTEGRITY OF DATA FROM LARGE, WELL–CONTROLLED TRIALS¹

EYLEA 2 mg (0.05 mL) Dosing Schedule¹

References

Wet AMD: Dosing Flexibility

Start With EYLEA. Stay With EYLEA.1

TRUST ≈8 YEARS OF EXTENSIVE CLINICAL EXPERIENCE AND THE INTEGRITY OF DATA FROM LARGE, WELL–CONTROLLED TRIALS1

EYLEA 2 mg (0.05 mL) Dosing Schedule1

References

Start With EYLEA. Stay With EYLEA.¹

TRUST ≈8 YEARS OF EXTENSIVE CLINICAL EXPERIENCE AND THE INTEGRITY OF DATA FROM LARGE, WELL–CONTROLLED TRIALS¹

EYLEA 2 mg (0.05 mL) Dosing Schedule¹