DME Anti-VEGF Therapy Study Results

EYLEA Achieved Rapid, Sustained Outcomes in DME¹

The power with EYLEA delivered rapid and sustained outcomes in the largest phase 3 anti-VEGF clinical trials completed to date in DME (N=862), with improved visual acuity at 52 and 100 weeks.¹

DME—Significant vision gains at 52 and 100 weeks¹

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^1,‡

Graph comparing EYLEA 2mg every 8 weeks, and EYLEA 2mg every 4 weeks in DME patients showing VISTA and VIVID ETDRS letters gained over initial and sustained response.

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.

*Best-corrected visual acuity.
^†Early Treatment Diabetic Retinopathy Study.
^‡Last observation carried forward; full analysis set.
^IISafety analysis set.
^¶Following 5 initial monthly doses.

Clinically significant improvement of ≥3 lines (≥15 letters of vision*) seen in DME at 52 and 100 weeks¹

A proportion of EYLEA patients gained 3 or more lines (≥15 letters of vision*) across all pivotal studies of patients with DME at 52 and 100 weeks.¹

% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)^1,†

Chart showing % patients who gained ≥15 ETDRS Letters at 52 and 100 weeks in the VISTA and VIVID trials.

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.

*Best-corrected visual acuity, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
^†Last observation carried forward; full analysis set.
^§Following 5 initial monthly doses.

EYLEA demonstrated results in patients with DME at 52 and 100 weeks¹—the majority of whom were anti–VEGF–treatment–naïve²

EYLEA patients who were anti–VEGF–naïve at baseline—57% in VISTA; 91% in VIVID²

On average, visual acuity gains achieved during the initial response period were sustained through 100 weeks⁴

Mean Change in BCVA,* as Measured by ETDRS^† Letters, at 100 Weeks vs Baseline in Anti–VEGF–Naïve Patients (post hoc, exploratory subgroup analysis)⁴

Chart showing mean change in BCVA at 100 weeks vs baseline in anti-VEGF-naïve patients.

The results of this exploratory endpoint requires cautious interpretation and could represent chance findings, as 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

*Best–corrected visual acuity.
^†Early Treatment Diabetic Retinopathy Study.
^‡Following 5 initial monthly doses.

EYLEA Results Regardless of Baseline Visual Acuity Studied^4,*

Whether patients presented with better or worse baseline vision, EYLEA demonstrated results in patients with DME at 100 weeks.⁴ Results are presented by prespecified subgroups of baseline visual acuity.⁴

Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)⁴

Graph showing diabetic macular edema patients' visual acuity gains at 100 weeks across baseline visual acuity subgroups.

Similar results were seen at 100 weeks in VIVID⁴

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

*Best–corrected visual acuity.
^†Early Treatment Diabetic Retinopathy Study.
^‡Following 3 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: VISION OUTCOMES

EYLEA Achieved Rapid, Sustained Outcomes in DME¹

DME—Significant vision gains at 52 and 100 weeks¹

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^1,‡

Clinically significant improvement of ≥3 lines (≥15 letters of vision*) seen in DME at 52 and 100 weeks¹

% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)^1,†

EYLEA demonstrated results in patients with DME at 52 and 100 weeks¹—the majority of whom were anti–VEGF–treatment–naïve²

Mean Change in BCVA,* as Measured by ETDRS^† Letters, at 100 Weeks vs Baseline in Anti–VEGF–Naïve Patients (post hoc, exploratory subgroup analysis)⁴

EYLEA Results Regardless of Baseline Visual Acuity Studied^4,*

Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)⁴

References

DME: VISION OUTCOMES

EYLEA Achieved Rapid, Sustained Outcomes in DME1

DME—Significant vision gains at 52 and 100 weeks1

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS† Letters, vs Baseline1,‡

Clinically significant improvement of ≥3 lines (≥15 letters of vision*) seen in DME at 52 and 100 weeks1

% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)1,†

EYLEA demonstrated results in patients with DME at 52 and 100 weeks1—the majority of whom were anti–VEGF–treatment–naïve2

Mean Change in BCVA,* as Measured by ETDRS† Letters, at 100 Weeks vs Baseline in Anti–VEGF–Naïve Patients (post hoc, exploratory subgroup analysis)4

EYLEA Results Regardless of Baseline Visual Acuity Studied4,*

Mean Change in BCVA,* as Measured by ETDRS† Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)4

References

EYLEA Achieved Rapid, Sustained Outcomes in DME¹

DME—Significant vision gains at 52 and 100 weeks¹

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^1,‡

Clinically significant improvement of ≥3 lines (≥15 letters of vision*) seen in DME at 52 and 100 weeks¹

% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)^1,†

EYLEA demonstrated results in patients with DME at 52 and 100 weeks¹—the majority of whom were anti–VEGF–treatment–naïve²

Mean Change in BCVA,* as Measured by ETDRS^† Letters, at 100 Weeks vs Baseline in Anti–VEGF–Naïve Patients (post hoc, exploratory subgroup analysis)⁴

EYLEA Results Regardless of Baseline Visual Acuity Studied^4,*

Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)⁴