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OUR DATA: Clinical Trial Results of EYLEA® (aflibercept)
Injection for Macular Edema following Retinal
Vein Occlusion (RVO)

Demonstrated in COPERNICUS and GALILEO

The safety and efficacy of EYLEA were assessed in 2 randomized, multicenter, double-masked, sham-controlled studies involving 358 patients with Macular Edema following Central Retinal Vein Occlusion (CRVO).1-3

Demonstrated in VIBRANT

The safety and efficacy of EYLEA was assessed in a randomized, multicenter, double-masked, controlled study involving 181 patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO).4

COPERNICUS and GALILEO Clinical Trials

THEIR VISION: Significant Improvement in Best-Corrected
Visual Acuity (BCVA) at 24 Weeks vs Control

EYLEA Significantly Improved Visual Acuity, as Measured by Early Treatment Diabetic Retinopathy
Study (ETDRS) Letters, in the Majority of Patients

Over 55% of all EYLEA patients gained ≥15 ETDRS letters at 24 weeks in the 2 pivotal trials.

COPERNICUS and GALILEO study designs: Two randomized, muticenter, double-masked, sham-controlled studies in patients with Macular Edema following CRVO. 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 control injections administered every 4 weeks (monthly) for the first 6 months to week 24.

THEIR VISION: Significant Improvement in Best-Corrected Visual Acuity (BCVA) at 24 Weeks

Sustained Improvement in BCVA, as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Letters, Over 24 Weeks

Efficacy was demonstrated by a statistically significant mean change in visual acuity in the pivotal trials.

Efficacy by Perfusion Status Analysis

EYLEA® (aflibercept) Injection Improved Visual Acuity Regardless of Perfusion Status1,3
  • The majority of patients who received EYLEA gained ≥15 letters by 24 weeks regardless of baseline perfusion status1,3

Efficacy by Time-to-Treatment Analysis

Earlier Intervention May Lead to Better Patient Outcomes in Macular Edema Following CRVO1-3
  • Several pivotal studies showed that patients receiving delayed treatment for Macular Edema following CRVO never attained the visual improvement of patients receiving earlier treatment4-6
  • In a 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 diagnosis1-3

OUR CLINICAL DATA: Reductions in Central Retinal
Thickness (CRT) Over 24 Weeks

Reductions in Mean CRT Were Observed in Prespecified Analyses2,3
  • Anatomic data were not used to influence treatment decisions

OUR SAFETY PROFILE: Similar Safety Profile vs Sham
Control in the Clinical Trials

  • Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis

OUR SAFETY PROFILE: Comparable to Sham Control

Serious Nonocular Adverse Reactions1

EYLEA was associated with comparable nonocular adverse reactions to sham control over the first 24 weeks in the clinical trials.*

* Events occurring in ≥2 patients.

  • Incidence of arterial thromboembolic events over the first 24 weeks was 0% with EYLEA vs 1.4% with sham control
SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
  • There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, 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. The incidence in the DME studies during the first year 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. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

COPERNICUS and GALILEO Study Designs

Two randomized, multicenter, double-masked, sham-controlled studies in patients with Macular Edema following CRVO (N=358). Patients were assigned in a 3:2 ratio to either 1) EYLEA® (aflibercept) Injection 2-mg administered every 4 weeks (monthly) for the first 6 months or 2) sham control injections administered every 4 weeks (monthly) for the first 6 months to week 24.

Primary Efficacy Endpoint
  • Percentage of patients gaining ≥15 letters at 24 weeks compared to baseline, as measured by ETDRS letters
Key Secondary Endpoint
  • Mean change in BCVA, as measured by ETDRS letters, from baseline to 24 weeks

Study Entry Criteria

Studied Across a Range of Patient Types

Inclusion criteria2,3

  • Patients naïve to anti-vascular endothelial growth factor (anti-VEGF) treatment with center-involved Macular Edema following CRVO (regardless of retinal perfusion status) diagnosed ≤9 months of study initiation
  • Age ≥18 years
  • Mean central retinal thickness of ≥250 µm
  • Baseline ETDRS BCVA score: 73 to 24 letters (Snellen equivalent: 20/40 to 20/320)
  • 68% to 84% of patients were perfused (<10 disc areas of capillary nonperfusion)

Exclusion criteria2,3

  • Bilateral retinal vein occlusion
  • History or presence of Age-related Macular Degeneration, diabetic retinopathy, or diabetic macular edema
  • History of vitreoretinal surgery in the study eye
  • Intraocular surgery in the preceding 3 months
  • Iris neovascularization
  • Previous panretinal or macular laser photocoagulation
  • Use of intraocular corticosteroids or antiangiogenic treatment in either eye
  • Pregnancy

Baseline Characteristics

Demographics at Baseline Were Well Balanced in the Clinical Trials2,3

The COPERNICUS study evaluated perfusion status for ≤2 months; the GALILEO study evaluated perfusion
status for <2 months.

    VIBRANT Clinical Trial

    THEIR VISION: Superior Improvement in Best-Corrected
    Visual Acuity (BCVA) at 24 Weeks vs Control

    EYLEA Significantly Improved Visual Acuity, as Measured by Early Treatment Diabetic Retinopathy Study
    (ETDRS) Letters, in the Majority of Patients vs Control in the VIBRANT Clinical Trial
    • Over 52% of all EYLEA patients gained ≥15 ETDRS letters in BCVA at 24 weeks in the pivotal trial

    VIBRANT study design: randomized, multicenter, double-masked, controlled study in which patients with Macular Edema following BRVO (N=181) were randomized to receive 1) EYLEA 2-mg administered every 4 weeks or 2) laser photocoagulation administered at baseline and subsequently as needed (control group).

    THEIR VISION: Significant Improvement in Best-Corrected Visual Acuity (BCVA) at 24 Weeks

    EYLEA Patients Demonstrated Sustained Improvement in BCVA, as Measured by Early Treatment Diabetic
    Retinopathy Study (ETDRS) Letters, Over 24 Weeks
    • Efficacy was demonstrated by a statistically significant mean change in visual acuity in the pivotal trial

    THEIR VISION: Reductions in Central Retinal Thickness (CRT)
    at 24 Weeks

    Reductions in Mean CRT Were Observed4
    • Anatomic data were not used to influence treatment decisions

    OUR SAFETY PROFILE: Demonstrated in the RVO Clinical Trials

    • Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis

    VIBRANT Study Design

    Randomized, multicenter, double-masked, controlled study in which patients with Macular Edema following BRVO (N=181) were randomized to receive 1) EYLEA® (aflibercept) Injection 2-mg administered every 4 weeks or 2) laser photocoagulation administered at baseline and subsequently as needed (control group)

    Primary Efficacy Endpoint
    • Proportion of patients gaining ≥15 ETDRS letters in BCVA at 24 weeks from baseline vs control
    Key Secondary Endpoint
    • Mean change in BCVA, as measured by ETDRS letters, at 24 weeks vs baseline

    Study Entry Criteria

    Studied Across a Range of Patient Types

    Inclusion criteria4

    • Adult treatment-naïve patients with BRVO or Hemi-Retinal Vein Occlusion (HRVO) causing edema of the macula center*
    • Occlusion within 12 months of study initiation
    • BCVA: ≤73–≥24 ETDRS letters (Snellen equivalent: 20/40–20/320) in the study eye

      *BRVO defined as : retinal hemorrahages or other biomicroscopic evidence of RVO and venous dialation in <2 retinal quadrants drained by the same vein; HRVO: 2 retinal quadrants.

    Exclusion criteria4

    • History of vitreoretinal surgery or expectation of such within 12 months
    • Any intraocular surgery within the previous 3 months
    • Non–BRVO-caused visual acuity reductions
    • Presence of diabetic macular edema or retinopathy (>1 microaneurysm outside the area of the vein occlusion), ocular inflammation, or uncontrolled glaucoma (intraocular pressure of ≥25 mm Hg or previous filtration surgery)
    • Periocular corticosteroid use within the previous 3 months
    • Prior treatment with intraocular corticosteroids, antiangiogenic drugs, scatter or panretinal laser, macular grid laser, or sector laser

    Baseline Characteristics

    Demographics at Baseline Were Well Balanced in the Clinical Trial4

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      IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
      +
      • 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.
      • 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. 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.
      • 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 floaters, intraocular pressure increased, and vitreous detachment.
      IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION

      EYLEA® (aflibercept) Injection is indicated for the treatment of patients with

      • Neovascular (Wet) Age-related Macular Degeneration (AMD): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
      • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly).
      • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with DME: The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

      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

      EYLEA and EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.

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