MEfRVO Anti-VEGF Therapy Study Results for Anatomic Outcomes

See EYLEA results in patients with MEfRVO at 24 weeks—all of whom were anti-VEGF-treatment-naïve^1,2

Anatomic outcomes at 24 weeks^2-4

Primary efficacy endpoint in the VIBRANT, COPERNICUS, and GALILEO trials: % patients gaining ≥15 letters at 24 weeks from baseline vs control. See primary endpoint results.

In prespecified analyses, EYLEA reduced central retinal thickness^2-4

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 24 Weeks From Baseline^2-4,†

Graph showing mean change in central retinal thickness at 24 weeks in the VIBRANT MEfBRVO study.

Graph showing mean change in central retinal thickness at 24 weeks in the COPERNICUS (MEfCRVO) study.

Graph showing mean change in central retinal thickness at 24 weeks in the GALILEO (MEfCRVO) study.

The results of these prespecified analyses require cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

Anatomic measures were not used to influence treatment decisions¹

VIBRANT study design: Randomized, multicenter, double-masked, controlled study in which patients with Macular Edema following BRVO (N=181; age range: 42-94 years, with a mean of 65 years) were randomized to receive 1) EYLEA 2 mg administered every 4 weeks or 2) laser photocoagulation administered at baseline and subsequently as needed (control group).

The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity at week 24 compared to baseline.

COPERNICUS and GALILEO study designs: Randomized, multicenter, double-masked, sham-controlled studies in patients with Macular Edema following CRVO (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 administered every 4 weeks (monthly) for the first 6 months or 2) sham injections (control) administered every 4 weeks (monthly) for a total of 6 injections.

In both studies, the primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity at week 24 compared to baseline.

*Optical coherence tomography.
^†Last observation carried forward; full analysis set.

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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.

References

EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
Campochiaro PA, Brown DM, Awh CC, et al. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011;118(10):2041-2049.
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.
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.

MEfRVO: Anatomy Outcomes

See EYLEA results in patients with MEfRVO at 24 weeks—all of whom were anti-VEGF-treatment-naïve1,2

Anatomic outcomes at 24 weeks2-4

In prespecified analyses, EYLEA reduced central retinal thickness2-4

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 24 Weeks From Baseline2-4,†

Anatomic measures were not used to influence treatment decisions1