DME Anti-VEGF Therapy Study Results for Anatomic Outcomes

Start EYLEA First-Line. In Prespecified Analyses, EYLEA Significantly Reduced Central Retinal Thickness in Patients With DME at 52 Weeks

Anatomic outcomes at 52 and 100 weeks¹

Primary efficacy endpoint in the VISTA and VIVID trials: Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline^1,†

Graph showing mean change in central retinal thickness at 52 and 100 weeks in the VIVID and VISTA trials.

The results of the 100 week exploratory endpoint requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

Anatomic measures were not used to influence treatment decisions²

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862; age range: 23-87 years, with a mean of 63 years) were randomized and received 1) EYLEA 2 mg administered every 8 weeks following 5 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; or 3) macular laser photocoagulation (control), at baseline and then as needed. Protocol-specified visits occurred every 28 (±7) days.

In both studies, the primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity at week 52, as measured by Early Treatment Diabetic Retinopathy Study letter score.

*Optical coherence tomography.
^†Last observation carried forward; full analysis set.
^§Following 5 initial monthly doses.

Power to Reduce Disease Severity²

DR in patients with DME—Significant improvement in DR severity at 100 weeks²

Primary efficacy endpoint in the VISTA and VIVID trials: Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.

VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2–Step Improvement in the ETDRS–DRSS* vs Control^2,†

Chart showing % patients achieving a ≥2–step improvement in the VISTA and VIVID trials.

*Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.
^†Last observation carried forward consists of patients with a baseline fundus photo.
^§Following 5 initial monthly doses.

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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.

DME: ANATOMY OUTCOMES

Start EYLEA First-Line. In Prespecified Analyses, EYLEA Significantly Reduced Central Retinal Thickness in Patients With DME at 52 Weeks

Anatomic outcomes at 52 and 100 weeks¹

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline^1,†

Power to Reduce Disease Severity²

VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2–Step Improvement in the ETDRS–DRSS* vs Control^2,†

References

DME: ANATOMY OUTCOMES

Start EYLEA First-Line. In Prespecified Analyses, EYLEA Significantly Reduced Central Retinal Thickness in Patients With DME at 52 Weeks

Anatomic outcomes at 52 and 100 weeks1

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline1,†

Power to Reduce Disease Severity2

VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2–Step Improvement in the ETDRS–DRSS* vs Control2,†

References

Anatomic outcomes at 52 and 100 weeks¹

Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline^1,†

Power to Reduce Disease Severity²

VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2–Step Improvement in the ETDRS–DRSS* vs Control^2,†