Treatment for Patients with DME: EYLEA® (aflibercept) Injection

EYLEA is an anti-VEGF therapy indicated for the treatment of patients with DME¹

EYLEA is administered via intravitreal injection by retina specialists and other ophthalmologists²

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.

DME is a complication of Diabetic Retinopathy (DR) that can occur anytime¹

In DME, EYLEA Achieved Significant Vision Gains Through 52 and 100 Weeks²

VISTA and VIVID Efficacy Results Through 52 Weeks (primary endpoint) and
100 Weeks (prespecified exploratory endpoint): Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^2,‡

Chart showing mean change in BCVA at 52 and 100 weeks in the VISTA and VIVID trials

*Best-corrected visual acuity.
^†Early Treatment Diabetic Retinopathy Study.
^‡Last observation carried forward; full analysis set.
^§P<0.01 vs control.
^IIFollowing 5 initial monthly doses.

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 BCVA at week 52, as measured by ETDRS letter score.

In DME, EYLEA Demonstrated Clinically Significant Visual Improvement of ≥3 Lines (≥15 Letters of Vision)²

% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 100 Weeks (prespecified exploratory endpoint) From Baseline vs Control^2,*

Percentage of Patients Who Gained ≥15 ETDRS Letters at 52 Weeks and 100 Weeks from Baseline vs Control

*Last observation carried forward; full analysis set.
^‡Following 5 initial monthly doses.

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

AAO = American Academy of Ophthalmology; anti-VEGF = anti–vascular endothelial growth factor.

See More Important Safety Information and Indications

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.

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.

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 for U.S. Doctors of Optometry.

References:

Macular Edema. National Eye Institute, National Institutes of Health website. http://bit.ly/2MGKMVG. Accessed January 14, 2020.
EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Ophthalmology. 1991;98(5 suppl):823-833.
Davis MD, Fisher MR, Gangnon RE, et al; for the Early Treatment Diabetic Retinopathy Study Research Group. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study report #18. Invest Ophthalmol Vis Sci. 1998;39(2):233-252.
Staurenghi G, Feltgen N, Arnold JJ, et al. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018;102(7):954-958.
American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. http://bit.ly/2SX3H2D. Accessed January 14, 2020.

EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.

11/2020
EYL.20.10.0065

EYLEA FOR
Diabetic
Macular Edema (DME)

The more you know about
anti-VEGF therapy for Diabetic
Macular Edema (DME), the better
you can inform your patients¹

EYLEA is an anti-VEGF therapy indicated for the treatment of patients with DME¹

DME is a complication of Diabetic Retinopathy (DR) that can occur anytime¹

In DME, EYLEA Achieved Significant Vision Gains Through 52 and 100 Weeks²

VISTA and VIVID Efficacy Results Through 52 Weeks (primary endpoint) and
100 Weeks (prespecified exploratory endpoint): Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^2,‡

In DME, EYLEA Demonstrated Clinically Significant Visual Improvement of ≥3 Lines (≥15 Letters of Vision)²

% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 100 Weeks (prespecified exploratory endpoint) From Baseline vs Control^2,*

EYLEA FOR Diabetic Macular Edema (DME)

The more you know about anti-VEGF therapy for Diabetic Macular Edema (DME), the better you can inform your patients1

EYLEA is an anti-VEGF therapy indicated for the treatment of patients with DME1

DME is a complication of Diabetic Retinopathy (DR) that can occur anytime1

In DME, EYLEA Achieved Significant Vision Gains Through 52 and 100 Weeks2

VISTA and VIVID Efficacy Results Through 52 Weeks (primary endpoint) and 100 Weeks (prespecified exploratory endpoint): Mean Change in BCVA,* as Measured by ETDRS† Letters, vs Baseline2,‡

In DME, EYLEA Demonstrated Clinically Significant Visual Improvement of ≥3 Lines (≥15 Letters of Vision)2

% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 100 Weeks (prespecified exploratory endpoint) From Baseline vs Control2,*

EYLEA FOR
Diabetic
Macular Edema (DME)

The more you know about
anti-VEGF therapy for Diabetic
Macular Edema (DME), the better
you can inform your patients¹

EYLEA is an anti-VEGF therapy indicated for the treatment of patients with DME¹

DME is a complication of Diabetic Retinopathy (DR) that can occur anytime¹

In DME, EYLEA Achieved Significant Vision Gains Through 52 and 100 Weeks²

VISTA and VIVID Efficacy Results Through 52 Weeks (primary endpoint) and
100 Weeks (prespecified exploratory endpoint): Mean Change in BCVA,* as Measured by ETDRS^† Letters, vs Baseline^2,‡

In DME, EYLEA Demonstrated Clinically Significant Visual Improvement of ≥3 Lines (≥15 Letters of Vision)²

% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 100 Weeks (prespecified exploratory endpoint) From Baseline vs Control^2,*