EYLEA FOR
Diabetic
Retinopathy (DR)

The more you know about
anti-VEGF therapy for DR, the
better you can inform your patients

EYLEA is an anti-VEGF therapy indicated for the treatment of patients with Diabetic Retinopathy (DR)1

EYLEA is administered via intravitreal injection by retina specialists and other ophthalmologists1

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.

EYLEA Improved DR Severity Scores in Patients With Moderately Severe to Severe Nonproliferative DR (NPDR)1,2

PANORAMA: Proportion of Patients Achieving a ≥2-Step Improvement in ETDRS-DRSS* Score From Baseline at 52 Weeks (a primary endpoint) and 100 Weeks (prespecified exploratory endpoint)1,2,‡

PANORAMA Trial: ETDRS-DRSS Score Improvement from Baseline at 52 and 100 Weeks

*ETDRS-DRSS = Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: An established grading scale for measuring the severity of DR.
Full analysis set.
The results of these exploratory endpoints require cautious interpretation, as a multiplicity adjustment has not been applied. Results are descriptive only.

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 diabetic macular edema (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.

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 proliferative DR (PDR) or anterior segment neovascularization (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.

Patients Were Randomly Assigned 1:1:1 to 1 of 3 Treatment Regimens1,2

Patients Randomly Assigned to: Eylea Every 16 weeks vs. 8 weeks vs. Sham Treatment
  • The recommended dose for EYLEA is 2 mg (0.05 mL) in DR 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 is the first phase 3 anti-VEGF trial specifically designed to
study patients with moderately severe to severe NPDR without DME


Power against disease progression—

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

Fewer Patients With Moderately Severe to Severe NPDR Progressed to PDR or ASNV or Developed CI-DME vs Sham Through Weeks 52 and 100 in the PANORAMA Study1,2

Progression to PDR or ASNV or Development of CI-DME Through Weeks 52 and 1001,2,*,†

NPDR Progression to PDR or ASNV or Development of CI-DME Through Week 52
Progression to PDR or ASNV or Development of CI-DME Through Week 100

*Full analysis set.

Composite endpoint of developing PDR or ASNV was diagnosed by either the reading center or investigator through week 100.

Event rate was estimated using the Kaplan-Meier method.

§EYLEA treatment groups: 3 initial monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks; 5 initial monthly injections, followed by 1 injection every 8 weeks in the first year and a different dosing regimen in the second year.

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

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

Through 52 weeks based on reading center score (% patients)1

Through 100 weeks based on reading center score (% patients)2


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

% Patients With a ≥2-Step Improvement on the ETDRS-DRSS From Baseline
at 100 Weeks (secondary endpoint: DR in patients with DME)1,*

Chart showing the % of patients achieving a ≥2-step improvement on ETDRS-DRSS at week 100 in the VISTA and VIVID trials

% Patients

VISTA
VIVID
P<0.01 vs control.

38%

EYLEA 2 mg
every 8 weeks
(n=148)

38%

EYLEA 2 mg
every 4 weeks
(n=153)

16%

Control
(n=150)
 

32%

EYLEA 2 mg
every 8 weeks
(n=101)

28%

EYLEA 2 mg
every 4 weeks
(n=97)

7%

Control
(n=99)
 

*Last observation carried forward consists of patients with a baseline fundus photo.

Following 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.


Example of a 2-Step Improvement on the DR Severity Scale3-6

Fundoscopic example of a 2-step improvement on the Diabetic Retinopathy severity scale

Scale is adapted from the ETDRS-DRSS, an established grading scale for measuring the severity of DR, as well as from the AAO.

EYLEA: an anti-VEGF therapy for the treatment of DR, with the power to1,2

  • Help improve diabetic retinopathy severity scores
  • Help stop disease progression to PDR/ASNV/CI-DME
  • Help prevent vision-threatening complications that can lead to blindness

AAO = American Academy of Ophthalmology;
anti-VEGF = anti–vascular endothelial growth factor;
BCVA = best-corrected visual acuity.

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. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
  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. 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.