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

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 Baseline2,‡

Chart showing mean change in BCVA at 52 and 100 weeks in the VISTA and VIVID trials 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 Control2,*

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 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:

  1. Macular Edema. National Eye Institute, National Institutes of Health website. http://bit.ly/2MGKMVG. Accessed January 14, 2020.
  2. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
  3. 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.
  4. 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.
  5. 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.
  6. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. http://bit.ly/2SX3H2D. Accessed January 14, 2020.