Clinically Significant Vision Gains (≥15 letters) Across 3 Robust Clinical
Trials in MEfRVO

Over half of patients with Macular Edema following Retinal Vein Occlusion achieved substantial improvements
in visual acuity within 6 months

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control1-4,*

*Last observation carried forward; full analysis set.

VIBRANT Study Design

Randomized, multicenter, double-masked, controlled study in which patients with MEfBRVO (N=181; age range: 42-94 years, with a mean of 65 years) were randomized to receive: 1) EYLEA 2 mg Q4 or 2) laser photocoagulation administered at baseline and subsequently as needed
(control group).1

The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in BCVA at Week 24 compared with baseline.1

COPERNICUS and GALILEO
Study Designs

Randomized, multicenter, double-masked, sham-controlled studies in patients with MEfCRVO (N=358; age range: 22-89 years, with a mean of 64 years). Patients were assigned in a 3:2 ratio to either: 1) EYLEA 2 mg Q4 for the first 6 months or 2) sham injections (control) Q4 for a total of 6 injections.1

In both studies, the primary efficacy endpoint was the proportion of patients who gained ≥15 letters in BCVA at Week 24 compared with baseline.1

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

Rapid, Sustained Improvements in Visual Acuity

EYLEA led to mean gains of 17 or more ETDRS letters at Month 6 in all 3 pivotal MEfRVO trials

Mean change in BCVA (ETDRS letters) through Month 6 from baseline1,5,*

*Last observation carried forward; full analysis set.

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

First-line Efficacy Across a Wide Range of Patient Types in MEfRVO1

Patients achieved clinically significant vision gains regardless of having better or worse than 20/200 vision at baseline

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by baseline BCVA (prespecified subgroup analysis)5,*

The results of this prespecified subgroup analysis require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.

Treatment effects in evaluable subgroups in each study were, in general, consistent with the results in the overall populations.1

*Last observation carried forward; full analysis set.

EYLEA demonstrated clinically significant vision gains regardless of baseline retinal perfusion

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by perfusion status (prespecified subgroup analysis)5,*

The results of this prespecified subgroup analysis require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.

Treatment effects in evaluable subgroups in each study were, in general, consistent with the results in the overall populations.1

*Last observation carried forward; full analysis set.

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

Earlier Treatment With EYLEA Led to Increased Vision Gains in MEfCRVO

A higher proportion of patients achieved significant vision gains when treated within 2 months of diagnosis

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by time to treatment initiation (protocol-specified subgroup analysis)5,*

*Last observation carried forward; full analysis set.

ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

CRT data with EYLEA2-4

Available in a
single-dose–strength PFS1

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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA 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.
Important Safety Information
    CONTRAINDICATIONS
  • EYLEA 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.
  • Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
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.

References
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021
  2. Campochiaro PA, Clark WL, Boyer DS, et al. lntravitreal aflibercept for macular edema following branch retinal vein occlusion: the 24-week results of the VIBRANT study. Ophthalmology. 2015;122(3):538-544. doi:10.1016/j.ophtha.2014.08.031
  3. Boyer D, Heier J, Brown DM, et al. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012;119(5):1024-1032. doi:10.1016/j.ophtha.2012.01.042
  4. Holz FG, Roider J, Ogura Y, et al. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013;97(3):278-284. doi:10.1136/bjophthalmol-2012-301504
  5. Data on file. Regeneron Pharmaceuticals, Inc.