Start With EYLEA

Start EYLEA first-line. EYLEA demonstrated powerful results in patients with Wet AMD at 52 weeks, DME at 52 and 100 weeks, DR in patients with DME at 100 weeks, DR at 24 and 52 weeks, and Macular Edema following CRVO at 24 weeks–most of whom were anti-VEGF-treatment-naïve.1-6

First-line* for Wet AMD—On average, visual acuity gains achieved during the initial response period were sustained through 52 weeks1

  • All patients in VIEW 1 and VIEW 2 were naïve to anti-VEGF treatment2
  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.
Mean Change in BCVA, as Measured by ETDRS Letters, vs Baseline at 52 Weeks (secondary endpoint)1,§ 
Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over 52 weeks for VIEW 1 and VIEW 2. Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over 52 weeks for VIEW 1 and VIEW 2.

VIEW 1 and VIEW 2 study designs: Two multicenter, double-masked studies in which patients with Wet AMD (N=2412; age range: 49-99 years, with a mean of 76 years) were randomized to receive 1) EYLEA 2 mg administered every 8 weeks following 3 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; 3) EYLEA 0.5 mg administered every 4 weeks; or 4) ranibizumab 0.5 mg administered every 4 weeks. Protocol–specified visits occurred every 28 (±3) days.

In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing <15 letters of visual acuity at week 52, compared to baseline.

Between week 52 and week 96, patients randomized to EYLEA 2 mg every 4 weeks or every 8 weeks continued on a regimen where dosing could be extended up to 12 weeks (3 months), based on regular assessments. The need for dosing was guided by investigator assessment of prespecified visual and anatomic outcomes. There was no active control comparison group that utilized a fixed dosing regimen in year 2. Efficacy endpoints evaluated after week 52 were exploratory and included the proportion of patients maintaining visual acuity, the mean change in best-corrected visual acuity from baseline, and the proportion of patients gaining 15 letters or more.

  • *First-line anti–vascular endothelial growth factor (anti-VEGF) treatment in VIEW 1 and VIEW 2.
  • Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • §Last observation carried forward; full analysis set.
  • Following 3 initial monthly doses.

Wet AMD patients with early persistent retinal fluid at 52 weeks. A post hoc analysis of the VIEW trials7

Mean Change in BCVA,* as Measured by ETDRS Letters, Over 52 Weeks vs Baseline (VIEW 1 and VIEW 2 post hoc analysis)7
Graph showing ETDRS Letters change. Plus 11.7 for EYLEA 2 mg every 4 weeks (n=115). Plus 7.5 for EYLEA 2 mg every 8 weeks (n=123). Graph showing ETDRS Letters change. Plus 11.7 for EYLEA 2 mg every 4 weeks (n=115). Plus 7.5 for EYLEA 2 mg every 8 weeks (n=123).
  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.
  • Early persistent fluid was defined as retinal fluid (intraretinal [cystic] or subretinal) at baseline and after 3 initial monthly anti-VEGF§ injections as seen on time-domain OCT7,II
  • ≈20% of Wet AMD patients treated with EYLEA experienced early persistent retinal fluid7
  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.
  • §Anti–vascular endothelial growth factor.
  • IIOptical coherence tomography.

Anatomic outcomes at 52 weeks2

Prespecified analysis of central retinal thickness2
Mean Change in Central Retinal Thickness, as Measured by OCT, at 52 Weeks From Baseline (exploratory endpoint)2,*
Graph showing Mean Change in Central Retinal Thickness, as Measured by OCT, at 52 Weeks From Baseline in VIEW 1 and VIEW 2. Graph showing Mean Change in Central Retinal Thickness, as Measured by OCT, at 52 Weeks From Baseline in VIEW 1 and VIEW 2.
  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.
  • *Last observation carried forward; full analysis set.
  • Following 3 initial monthly doses.
Anatomic measures did not influence treatment decisions in Year 1 but were considered in Year 21
In a post hoc analysis, EYLEA was an effective drying agent, with a demonstrated ability to dry the retina2
Proportion of Patients With a Dry Retina* at 52 Weeks (post hoc endpoint)2
Graph showing that 65% of patients treated with EYLEA had a dry retina at 52 weeks vs 64% with ranibizumab in VIEW 1 and 80% with EYLEA vs 60% with ranibizumab in VIEW 2. Graph showing that 65% of patients treated with EYLEA had a dry retina at 52 weeks vs 64% with ranibizumab in VIEW 1 and 80% with EYLEA vs 60% with ranibizumab in VIEW 2.
  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.
  • *Defined as the absence of cystic intraretinal edema and subretinal fluid on OCT.
  • Following 3 initial monthly doses.
Anatomic measures did not influence treatment decisions in Year 1 but were considered in Year 21

First-line* in DME—On average, visual acuity gains achieved during the initial response period were sustained through 100 weeks3

  • EYLEA patients who were anti-VEGF-naïve at baseline—57% in VISTA; 91% in VIVID4
  • 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 BCVA, as Measured by ETDRS Letters, at 100 Weeks vs Baseline in Anti-VEGF-Naïve Patients (post hoc, exploratory subgroup analysis)3
EYLEA 2 mg every 8 weeks - VISTA 11.3, VIVID 8.9. EYLEA 2 mg every 4 weeks - VISTA 12.0, VIVID 11.2. Control - VISTA 2.1, VIVID 0.8. EYLEA 2 mg every 8 weeks - VISTA 11.3, VIVID 8.9. EYLEA 2 mg every 4 weeks - VISTA 12.0, VIVID 11.2. Control - VISTA 2.1, VIVID 0.8.
  • Treatment effects in evaluable subgroups in each study were in general consistent with the results in the overall populations

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.

  • *First-line anti–vascular endothelial growth factor (anti-VEGF) treatment in the majority of patients in VISTA and VIVID.
  • Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • §Following 5 initial monthly doses.

Anatomic outcomes at 52 and 100 weeks8

In prespecified analyses, EYLEA significantly reduced central retinal thickness8
Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline8,†
Graph showing Mean Change in Central Retinal Thickness, as Measured by OCT, at 52 and 100 weeks From Baseline in VIVID and VISTA Graph showing Mean Change in Central Retinal Thickness, as Measured by OCT, at 52 and 100 weeks From Baseline in VIVID and VISTA
  • 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.
  • *Optical coherence tomography.
  • Last observation carried forward; full analysis set.
  • §Following 5 initial monthly doses.
Anatomic measures were not used to influence treatment decisions1

Efficacy and safety data of EYLEA in DR are derived from the PANORAMA, VISTA, and VIVID studies1

DR severity scales: Useful when describing the clinical features of DR at various stages, allowing for proper diagnosis and appropriately timed intervention with a goal to help stop or reverse disease progression9-12

Detection of disease by fundus examination: Fundus photography is typically more sensitive in detecting DR lesions than other imaging methods used in practice13

DR Severity Scale*

Diabetic Retinopathy Severity Scale: Mild Nonproliferative DR (NPDR) - Microaneurysms only, Moderate NPDR - More than just microaneurysms, but less than severe NPDR, Moderately Severe NPDR - Any of the following: Mild intraretinal microvascular abnormalities in 4 quadrants, Severe retinal hemorrhages in 2-3 quadrants, Venous beading in 1 or more quadrants, Severe NPDR - Any of the following (4-2-1 rule) and no signs of proliferative DR (PDR): Severe intraretinal hemorrhages and microaneurysms in each of 4 quadrants, Definite venous beading in 2 or more quadrants, Moderate intraretinal microvascular abnormalilites in 1 or more quadrants, PDR: One or both of the following: Neovascularization, Vitreous/preretinal hemorrhage.
  • The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.
  • *Adapted from the American Academy of Ophthalmology (AAO) and Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale (ETDRS-DRSS).

Example of a 2-Step Regression on the DR Severity Scale

Example of 2-step regression on the diabetic retinopathy severity scale showing change from severe NPDR to Moderate NPDR. Example of 2-step regression on the diabetic retinopathy severity scale showing change from severe NPDR to Moderate NPDR.

POWER TO REDUCE DISEASE SEVERITY

EYLEA significantly improved DR severity scores at 24 weeks and 52 weeks in patients with moderately severe to severe nonproliferative DR (NDPR)1

PANORAMA is the first phase 3 anti-VEGF trial specifically designed to study patients with moderately severe to severe NPDR without DME

PANORAMA 24-Week and 52-Week Efficacy Outcomes (primary endpoint): Proportion of Patients Achieving a ≥2-Step Improvement in ETDRS-DRSS* Score From Baseline1,†
Graph showing proportion of patients achieving a ≥2-step improvement on the ETDRS-DRSS from baseline. Week 24: EYLEA 58% vs Sham 6%, Week 52: EYLEA 80% vs Sham 15%. Graph showing proportion of patients achieving a ≥2-step improvement on the ETDRS-DRSS from baseline. Week 24: EYLEA 58% vs Sham 6%, Week 52: EYLEA 80% vs Sham 15%.
Patients Were Randomly Assigned 1:1:1 to 1 of 3 Treatment Regimens1
Patients were randomly assigned one of three treatment regimens: 1. EYLEA 2 mg every 16 weeks 2. EYLEA 2 mg every 8 weeks 3. Sham Treatment Patients were randomly assigned one of three treatment regimens: 1. EYLEA 2 mg every 16 weeks 2. EYLEA 2 mg every 8 weeks 3. Sham Treatment
RECOMMENDED DOSING
  • The recommended dose for EYLEA in DR is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months)1
  • Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every-4-week (monthly) dosing after the first 20 weeks (5 months)1

PANORAMA study design: Multicenter, double-masked, controlled study in which patients with moderately severe to severe NPDR (ETDRS-DRSS: 47 or 53) without central-involved DME (CI-DME) (N=402; age range: 25-85 years, with a mean of 56 years) were randomized 1:1:1 to receive 1) 3 initial monthly EYLEA 2 mg injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks (EYLEA 2Q16); 2) 5 initial monthly EYLEA 2 mg injections, followed by 1 injection every 8 weeks (EYLEA 2Q8); or 3) sham treatment. Protocol-specified visits occurred every 28±7 days for the first 5 visits, then every 8 weeks (56±7 days).1

The primary efficacy endpoint was the proportion of patients who improved by ≥2 steps on the ETDRS-DRSS from baseline to week 24 in the combined EYLEA groups vs sham and at week 52 in the EYLEA 2Q16 and 2Q8 groups individually vs sham. A secondary endpoint was the proportion of patients developing the composite endpoint of proliferative DR or anterior segment neovascularization, or development of CI-DME, through week 52. An additional prespecified exploratory endpoint was a ≥2-step worsening on the ETDRS-DRSS score through week 52.


  • *Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.
  • Full analysis set.

Power Against Disease Progression

EYLEA can help prevent DR vision-threatening complications that can lead to blindness1,3
Significantly Fewer Moderately Severe to Severe NPDR Patients Progressed to Proliferative DR (PDR) or Anterior Segment Neovascularization (ASNV) or Developed Central-Involved DME (CI-DME) vs Sham Through Week 52 in the PANORAMA Study1,3,*
Progression to PDR or ASNV or development of CI-DME through week 52
Chart showing relative risk reduction of patients developing a VTC Chart showing relative risk reduction of patients developing a VTC
  • *Full analysis set.
  • EYLEA treatment groups: 3 initial monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks (2Q16); 5 initial monthly injections, followed by 1 injection every 8 weeks (2Q8).

Start With EYLEA to Help Stop Progression to PDR1

0% of patients progressed to PDR (defined as ≥2-step worsening in ETDRS-DRSS score) in the EYLEA 2Q8 group (hazard ratio = 0.00) and 2% of patients in the EYLEA 2Q16 group (hazard ratio = 0.11) vs 12% with sham through 52 weeks based on reading center score.1

All patients were treatment-naïve to focal or grid laser photocoagulation, panretinal photocoagulation, and any anti-VEGF treatment.3 Composite endpoint of developing PDR or ASNV was diagnosed by either the reading center or investigator through week 52. Event rate was estimated using the Kaplan-Meier method.1

DR in patients with DME—Significant improvement in DR severity at 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.
VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2-Step Improvement in the ETDRS-DRSS* vs Control1,†
EYLEA for DR in Patients with DME vs control graph showing percentage of patients achieving a greater than 2-step improvement in the ETDRS. EYLEA for DR in Patients with DME vs control graph showing percentage of patients achieving a greater than 2-step improvement in the ETDRS.
  • *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.

Macular Edema following CRVO—Earlier intervention may lead to better patient outcomes3

  • All patients in COPERNICUS and GALILEO were anti-VEGF*-naïve3
  • Primary efficacy endpoint in the COPERNICUS and GALILEO trials: % patients gaining ≥15 letters at 24 weeks from baseline vs control. See primary endpoint results.
% Patients Gaining ≥15 ETDRS Letters at 24 Weeks by Time to Treat From Baseline (protocol-specified subgroup analysis)3,‡
Graph showing COPERNICUS and GALILEA time to treatment for EYLEA versus sham control. Graph showing COPERNICUS and GALILEA time to treatment for EYLEA versus sham control.

COPERNICUS and GALILEO study designs: Randomized, multicenter, double-masked, sham-controlled studies in patients with Macular Edema following CRVO (N=358; age range: 22-89 years, with a mean of 64 years). Patients were assigned in a 3:2 ratio to either 1) EYLEA 2 mg administered every 4 weeks (monthly) for the first 6 months or 2) sham injections (control) administered every 4 weeks (monthly) for a total of 6 injections.

In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in best-corrected visual acuity at week 24 compared to baseline.

  • *Anti–vascular endothelial growth factor.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.

Anatomic outcomes at 24 weeks5,6

In prespecified analyses, EYLEA significantly reduced central retinal thickness5,6
Mean Change in Central Retinal Thickness, as Measured by OCT,* at 24 Weeks From Baseline5,6,†
Graph showing Mean Change in Central Retinal Thickness in COPERNICUS. EYLEA -457 vs Sham -145 at 24 weeks. Graph showing Mean Change in Central Retinal Thickness in COPERNICUS. EYLEA -457 vs Sham -145 at 24 weeks.
Graph showing Mean Change in Central Retinal Thickness in GALILEO. EYLEA -449 vs Sham -169 at 24 weeks. Graph showing Mean Change in Central Retinal Thickness in GALILEO. EYLEA -449 vs Sham -169 at 24 weeks.
  • Primary efficacy endpoint in the COPERNICUS and GALILEO trials: % patients gaining ≥15 letters at 24 weeks from baseline vs control. See primary endpoint results.
  • *Optical coherence tomography.
  • Last observation carried forward; full analysis set.
Anatomic measures were not used to influence treatment decisions1
Early intervention may help improve outcomes14-16

Several pivotal studies showed that patients receiving delayed treatment for Macular Edema following CRVO never attained the visual improvement of patients receiving earlier treatment14-16

In the COPERNICUS and GALILEO protocol-specified subgroup analysis, visual acuity improvements were quantitatively larger in patients treated within 2 months of diagnosis vs patients treated 2 or more months after diagnosis3

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Find out more about EYLEA's flexible dosing options for certaian approved indications in a 2mg formulation.
Dosing with EYLEA

EYLEA offers flexible dosing options
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See More Important Safety Information and Indications
  • 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 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. May 2019.
  2. Heier JS, Brown DM, Chong V, et al; for the VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548.
  3. Data on file. Regeneron Pharmaceuticals, Inc.
  4. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
  5. Boyer D, Heier J, Brown DM, et al. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012;119(5):1024-1032.
  6. Holz FG, Roider J, Ogura Y, et al. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013;97(3):278-284.
  7. Jaffe GJ, Kaiser PK, Thompson D, et al. Differential response to anti-VEGF regimens in age-related macular degeneration patients with early persistent retinal fluid. Ophthalmology. 2016;123(9):1856-1864.
  8. 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.
  9. 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.
  10. Davis MD, Fisher MR, Gangnon RE, et al. 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.
  11. Staurenghi G, Feltgen N, Arnold JJ, et al; for the VIVID-DME and VISTA-DME Study Investigators. 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.
  12. AAO Preferred Practice Pattern: Diabetic Retinopathy. American Academy of Ophthalmology website. https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp-updated-2017. Accessed February 14, 2019.
  13. Gangaputra S, Lovato JF, Hubbard L, et al; for the ACCORD Eye Research Group. Comparison of standardized clinical classification with fundus photograph grading for the assessment of diabetic retinopathy and diabetic macular edema severity. Retina. 2013;33(7):1393-1399.
  14. Campochiaro PA, Brown DM, Awh CC, et al. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011;118(10):2041-2049.
  15. Haller JA, Bandello F, Belfort R Jr, et al; for the Ozurdex GENEVA Study Group. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology. 2011;118(12):2453-2460.
  16. Brown DM, Heier JS, Clark WL, et al. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013;155(3):429-437.e7.