EYLEA Significantly Improved DR Severity Scores at 24 Weeks and 52 Weeks in Patients With Moderately Severe to Severe Nonproliferative DR (NPDR)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 endpoints): 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%.

PANORAMA study design: Multicenter, double–masked, controlled study in which patients with moderately severe to severe nonproliferative DR (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 randomly assigned in a 1:1:1 ratio to 1 of 3 dosing regimens: 1) 3 initial monthly EYLEA 2 mg injections followed by one injection after 8 weeks and then one injection every 16 weeks; 2) 5 monthly EYLEA 2 mg injections followed by one injection every 8 weeks; and 3) sham treatment. Protocol–specified visits occurred every 28±7 days for the first 5 visits, then every 8 weeks (56±7 days).

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 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.

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, efficacy endpoints included the mean change from baseline in best-corrected visual acuity, as measured by ETDRS letter score, at 52 weeks (primary endpoint) and 100 weeks (secondary endpoint). The percentage of patients with a ≥2-step improvement on the ETDRS-DRSS (an established grading scale for measuring the severity of DR) from baseline at 100 weeks was 38%, 38%, and 16% in VISTA and 32%, 28%, and 7% in VIVID with EYLEA 2 mg every 8 weeks after 5 initial monthly doses, EYLEA 2 mg every 4 weeks, and control, respectively (secondary endpoint).

  • anti-VEGF = anti–vascular endothelial growth factor.
  • *Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.
  • Full analysis set.
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


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

Power Against Disease Progression

EYLEA helps prevent DR vision–threatening complications that can lead to blindness1,2

Significantly fewer patients with moderately severe to severe NPDR 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 study
Progression to PDR or ASNV or Development of CI–DME Through Week 521,2,*
Chart showing the % patients with disease progression to PDR or ASNV or development of CI-DME through week 52, as well as the relative risk reduction with EYLEA treatment. Chart showing the % patients with disease progression to PDR or ASNV or development of CI-DME through week 52, as well as the relative risk reduction with EYLEA treatment.

  • *Full analysis set.
  • EYLEA treatment groups: 3 initial monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks (2 mg every 16 weeks); 5 initial monthly injections, followed by 1 injection every 8 weeks (2 mg every 8 weeks).

0% of patients progressed to PDR (defined as ≥2-step worsening on the ETDRS-DRSS score) in the EYLEA 2 mg every-8-week group (hazard ratio = 0.00) and 1.6% of patients in the EYLEA 2 mg every-16-week group (hazard ratio = 0.11) vs 11.9% with sham at 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.2 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

Anatomic Outcomes at 52 Weeks2

EYLEA patients had reductions in central retinal thickness2

Mean Change in Central Retinal Thickness, as Measured by OCT,* From Baseline at 52 Weeks (exploratory endpoint)2,†

Graph showing reductions in central retinal thickness at 52 weeks. Graph showing reductions in central retinal thickness at 52 weeks.

  • *Optical coherence tomography.
  • Last observation carried forward; full analysis set.
  • §EYLEA treatment groups: 3 initial monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks (2 mg every 16 weeks); 5 initial monthly injections, followed by 1 injection every 8 weeks (2 mg every 8 weeks).
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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 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. August 2019.
  2. Data on file. Regeneron Pharmaceuticals, Inc.