Start EYLEA Earlier in Appropriate Patients With NPDR

Demonstrated efficacy outcomes in PANORAMA, the first phase 3 anti-VEGF trial specifically designed to study patients with moderately severe to severe NPDR without DME.1

EYLEA improved DR severity scores

Patients achieving a 2-step improvement in ETDRS-DRSS score at Month 6 and Years 1 and 2 from baseline1,2,*

The results of exploratory endpoints require cautious interpretation, as a multiplicity adjustment has not been applied. Results are descriptive only.

ETDRS-DRSS is an established grading scale for measuring the severity of DR.

PANORAMA Study Design

Multicenter, double-masked, controlled clinical study in which patients with moderately severe to severe NPDR (ETDRS-DRSS: 47 or 53) without CI-DME (N=402; age range: 25-85 years, with a mean of 56 years) were randomized to receive 1 of 2 EYLEA dosing regimens or sham. Protocol-specified visits occurred every 28±7 days for the first 5 visits, then every 8 weeks (56±7 days). Between Week 52 and Week 96, patients randomized to one of the EYLEA arms received a different dosing regimen.1,2

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. Secondary endpoints included proportion of patients developing PDR or ASNV; development of CI-DME; and composite endpoint of PDR or ASNV or CI-DME through Week 52. All endpoints at Week 100 were prespecified exploratory.1,2

VISTA and VIVID Study Designs

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 studies, efficacy endpoints included the mean change from baseline in BCVA (ETDRS letters) at Year 1 (primary endpoint) and Year 2 (secondary endpoint). The percentage of patients with a ≥2-step improvement on the ETDRS-DRSS from baseline at Year 2 was 38%, 38%, and 16% in VISTA and 32%, 28%, and 7% in VIVID with EYLEA Q8 after 5 initial monthly doses, EYLEA Q4, and control, respectively (secondary endpoint).1

anti-VEGF, anti–vascular endothelial growth factor; ASNV, anterior segment neovascularization; BCVA, best-corrected visual acuity; CI-DME, central-involved Diabetic Macular Edema; ETDRS, Early Treatment Diabetic Retinopathy Study; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy; Q4, every 4 weeks; Q8, every 8 weeks; Q16, every 16 weeks.

Patients Were Randomly Assigned 1:1:1 to 1 of 3 Treatment Regimens in PANORAMA1,2

Recommended dosing

The recommended dose for EYLEA in DR is 2 mg (0.05 mL) administered by intravitreal injection Q4 (≈every 28 days, monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection Q8 (2 months).1

Although EYLEA may be dosed as frequently as 2 mg Q4 (≈every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed Q4 compared with Q8. Some patients may need Q4 (monthly) dosing after the first 20 weeks (5 months).1

No new safety signals compared with the known safety profile of EYLEA in the DR population.2

Efficacy and safety data of EYLEA in DR are derived from the VISTA, VIVID, and PANORAMA studies.1

Q4, every 4 weeks; Q8, every 8 weeks; Q16, every 16 weeks.

EYLEA Reduced the Risk of Vision-Threatening Complications

EYLEA helped prevent central-involved DME (CI-DME) and vision-threatening complications defined as PDR and anterior segment
neovascularization (ASNV), which can lead to blindness.1,2

Cumulative incidence of progression to PDR, ASNV, or CI-DME at Year 11,2,*,†

Cumulative incidence of progression to PDR, ASNV, or CI-DME at Year 21,2,*,†

The results of these exploratory endpoints require cautious interpretation, as a multiplicity adjustment has not been applied.

Start with EYLEA to help
prevent progression to PDR/
ASNV or development of CI-DME

Progression to PDR (defined as ≥2-step worsening on ETDRS-DRSS score)1,2,†

Through Year 1 based on reading center score (% of patients)1

  • EYLEA Q8§: 0% (hazard ratio: 0.00)
  • EYLEA Q16§: 1.6% (hazard ratio: 0.11)
  • Sham: 11.9%

Through Year 2 based on reading center score (% of patients)2

  • EYLEA Q16§: 4.5% (hazard ratio: 0.19)
  • Sham: 20.2%

ASNV, anterior segment neovascularization; CI-DME, central-involved Diabetic Macular Edema; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy
Severity Scale; NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy; Q8, every 8 weeks; Q16, every 16 weeks.

Reduction in Central Retinal Thickness

Mean change in CRT through Years 1 and 2 from baseline2,*

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

CRT, central retinal thickness; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; Q16, every 16 weeks.

Flexible dosing options
with EYLEA PFS1

Patients with DR are at risk
of developing
vision-
threatening complications2

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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. Wykoff CC. Intravitreal aflibercept for moderately severe to severe non-proliferative diabetic retinopathy (NPDR): 2-year outcomes of the phase 3 PANORAMA study. Data presented
    at: Angiogenesis, Exudation, and Degeneration Annual Meeting; February 8, 2020; Miami, FL.
  3. Data on file. Regeneron Pharmaceuticals, Inc.