EYLEA Achieved Rapid and Sustained Outcomes in DME

Demonstrated efficacy outcomes in VISTA and VIVID, phase 3 anti-VEGF trials in Diabetic Macular Edema (N=862).1

Mean change in BCVA (ETDRS letters) at Year 1 from baseline1-4,*

P<0.01 vs control at Year 1.

Mean BCVA (ETDRS letters) through
Years 1, 2, and 3 from baseline
(prespecified measurements)1-5,*

Mean BCVA (ETDRS letters) was measured from baseline to Year 1 as part of the primary analysis and to Years 2 and 3 as part of the prespecified
exploratory analyses and is descriptive only.

VISTA and VIVID Study Design

Two randomized, multicenter, double-masked, controlled clinical 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 Q8 following 5 initial monthly doses; 2) EYLEA 2 mg Q4; or 3) macular laser photocoagulation (control) at baseline and then as needed. Protocol-specified visits occurred every 28 (±7) days.1

In both clinical studies, the primary efficacy endpoint was the mean change from baseline in BCVA at Week 52, as measured by ETDRS letter score.1

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

EYLEA Improved Vision From 20/63 to 20/40

Mean change in visual acuity at Year 3 (prespecified exploratory endpoint)2,5

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

  • Patients gained a mean of 10 letters after the initial dosing phase (Week 20) and largely maintained gains through Year 32,5

≥20/40 vision is often required to retain driving privileges.*

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

Impact of Treatment Delay on Visual Acuity Outcomes

Integrated VISTA and VIVID Results
Mean BCVA (ETDRS letters) through Year 2 from baseline in patients who received EYLEA4,6

Mean BCVA (ETDRS letters) in patients who received laser and were then rescued with EYLEA starting from Month 6 (post hoc analysis
of a subgroup)4,6,*

The analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

Suboptimal visual outcomes after delayed anti-VEGF treatment may be potentially related to the damaging permeability effects from long-term
VEGF overexpression that results in persistent retinal edema.6

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; BL, baseline; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

Clinically Significant Improvement of ≥3 Lines of Vision at Year 1

Proportion of patients who gained ≥15 ETDRS letters at Years 1, 2, and 3 from baseline vs control1-3,5,*

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

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

First-line EYLEA—Vision Gains in Anti-VEGF–Naïve Patients

The majority of EYLEA patients in VISTA (57%) and VIVID (91%) had no prior anti-VEGF treatment.1,2

On average, initial mean vision gains of ≈10 letters were sustained at Year 2 in anti-VEGF–naïve patients

Mean change in BCVA (ETDRS letters) at Year 2 from baseline in anti-VEGF–naïve patients (post hoc subgroup analysis)2,4,7

The analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

Treatment effects in evaluable subgroups in each study were, in general, consistent with the results in the overall populations.2,4

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

CRT data with EYLEA2,3,5

Dosing flexibility with
EYLEA in DME1

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See More 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.
Important Safety Information
    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.
  • Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
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
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021
  2. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j.ophtha.2014.05.006
  3. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):
    2044-2052. doi:10.1016/j.ophtha.2015.06.017
  4. Data on file. Regeneron Pharmaceuticals, Inc.
  5. Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016;123(11):2376-2385. doi:10.1016/j.ophtha.2016.07.032
  6. Wykoff CC, Marcus DM, Midena E, et al. Intravitreal aflibercept injection in eyes with substantial vision loss after laser photocoagulation for diabetic macular edema: subanalysis of the VISTA and VIVID randomized clinical trials. JAMA Ophthalmol. 2017;135(2):107-114. doi:10.1001/jamaophthalmol.2016.4912
  7. Do V, Nguyen QD, Vitti R, et al. Intravitreal aflibercept injection in diabetic macular edema patients with and without prior anti-vascular endothelial growth factor treatment: outcomes from the phase 3 program. Ophthalmology. 2016;123(4):850-857. doi:10.1016/j.ophtha.2015.11.008