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OUR CLINICAL DATA: Demonstrated in the Largest Wet
Age-related Macular Degeneration (Wet AMD) Clinical Trials
With EYLEA® (aflibercept) Injection

Largest phase 3 clinical trials for Wet AMD treatment to date1,2

The efficacy of EYLEA was demonstrated in 2 randomized, multicenter, double-masked, active-controlled studies (VIEW 1 and VIEW 2) involving 2412 patients with Wet AMD.1,2

VIEW 1 and VIEW 2 Clinical Trials

YOUR ART: Demonstrated Efficacy With Fewer Injections

EYLEA 2-mg injected every 8 weeks following 3 initial monthly doses (every 4 weeks) demonstrated clinically equivalent efficacy at
52 weeks to ranibizumab 0.5-mg injected every 4 weeks in Wet AMD.3

VIEW 1 and VIEW 2 study designs: Two multicenter, double-masked studies in which patients with Wet AMD (N=2412) were randomized to receive 1) EYLEA 2-mg administered every 8 weeks following 3 initial monthly doses every 4 weeks; 2) EYLEA 2-mg administered every 4 weeks; 3) EYLEA 0.5-mg administered every 4 weeks; and 4) ranibizumab 0.5-mg administered every 4 weeks. Data are presented through week 52, the primary endpoint.

THEIR VISION: Extended Dosing Without Loss of Efficacy
Over 52 Weeks

Demonstrated Efficacy With Every-8-Weeks Dosing Following 3 Initial Monthly Doses4

EYLEA 2-mg every 8 weeks demonstrated sustained improvement of visual acuity over 52 weeks in the 2 pivotal trials in a broad range of Wet AMD patients.4

* Last observation carried forward; full analysis set.
Following 3 initial monthly doses (every 4 weeks).

Visual Acuity by Line Analysis

Demonstrated Efficacy3

Improvement and maintenance of visual acuity in the EYLEA® (aflibercept) Injection treatment groups:

  • 94% to 95% of patients gained ≥15 letters at 52 weeks from baseline
  • 78% to 94% of patients maintained vision at 52 weeks
* Versus baseline BCVA, as measured by ETDRS letters score; last observation carried forward; full analysis set.
Following 3 initial monthly doses (every 4 weeks).

20/40 Vision Analysis

EYLEA® (aflibercept) Injection Showed Improvement in Visual Acuity to ≥20/403

The proportion of patients in the EYLEA treatment groups achieving ≥20/40 BCVA was 42% of all EYLEA patients in VIEW 1 and 31% of all EYLEA patients in VIEW 2 at 52 weeks vs baseline.

* Versus baseline BCVA, as measured by ETDRS letters score; last observation carried forward; full analysis set.
Following 3 initial monthly doses (every 4 weeks).

OUR CLINICAL DATA: Reductions in Central Retinal Thickness (CRT) Over 52 Weeks vs Baseline

In a Prespecified Analysis, a Reduction in CRT Was Observed at Week 523

* Last observation carried forward; full analysis set.
Following 3 initial monthly doses (every 4 weeks).
  • Anatomic data were not used to influence treatment decisions

OUR SAFETY PROFILE: Demonstrated Safety Profile in the Pivotal Trials

Rates of adverse reactions across all treatment groups were similar in the 2 large, pivotal trials.

  • Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, and endophthalmitis
EYLEA Requires No Dose Adjustment in Geriatric Patients* or in Patients With Renal Impairment
  • No significant differences in efficacy or safety were seen with increasing age in the clinical trials

*In the EYLEA phase 3 clinical trials, 76% of patients were aged ≥65 years and 46% were aged ≥75 years.
Pharmacokinetic analysis of a subgroup of patients (n=492) in one Wet AMD study, of which 43% had renal impairment (mild, n=120; moderate, n=74; and severe, n=16), revealed no differences in plasma concentrations of free aflibercept after intravitreal administration every 4 or 8 weeks.

OUR SAFETY PROFILE: Serious Nonocular (Systemic)
Adverse Reactions Were Similar Among Patients
Receiving EYLEA and Ranibizumab5

Blood Pressure/Hypertension

No Increase in Mean Blood Pressure Was Observed Over 52 Weeks3
  • Among all treatment groups in the VIEW trials, based on a prespecified analysis3
  • Change in blood pressure is a sensitive biomarker of systemic anti-endothelial growth factor (anti-VEGF) activity6-9
  • As approved in the VIEW trials, hypertension was reported as an adverse event in 8.9% of all EYLEA® (aflibercept) Injection patients and 9.7% of ranibizumab patients and as a serious adverse event in 0.3% of all patients3
Incidence of Hypertension Reported as an Adverse Event Was Comparable Across All Treatment Groups3
  • Hypertension was reported as a serious adverse event with a low incidence3

VIEW 1 and VIEW 2 Study Designs

Two multicenter, double-masked studies in which patients with Wet AMD (N=2412) were randomized to receive 1) EYLEA® (aflibercept) Injection 2-mg administered every 8 weeks following 3 initial doses every 4 weeks; 2) EYLEA 2-mg administered every 4 weeks; 3) EYLEA 0.5-mg administered every 4 weeks; and 4) ranibizumab 0.5-mg administered every 4 weeks. Data are presented through week 52, the primary endpoint.

Primary Endpoint
  • Maintenance of vision (<15 letters lost) based on best-corrected visual acuity (BCVA), as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, at 52 weeks
Key Secondary Endpoint
  • Mean change in BCVA, as measured by ETDRS letter score, at 52 weeks from baseline
  • Proportion of patients who gained ≥15 letters of vision at 52 weeks from baseline

Study Entry Criteria

Studied Across a Broad Range of Wet AMD Patients4

Inclusion criteria for the pivotal trials included4

  • Patients aged ≥50 years with active subfoveal choroidal neovascularization (CNV) lesions secondary to Wet AMD, including juxtafoveal lesions with leakage affecting the fovea
  • CNV comprising ≥50% of total lesion size
  • BCVA between 73 and 25 ETDRS letters (Snellen equivalent: 20/40 to 20/320)
  • Patients with all lesion types could be enrolled

Exclusion criteria included3,4

  • History or presence of diabetic retinopathy, diabetic macular edema, or other retinal vascular disease (other than Wet AMD) in either eye
  • Prior or concomitant treatment of Wet AMD (including an investigational agent or anti–vascular endothelial growth factor [anti-VEGF] therapy) in the study eye
  • Presence of other causes of choroidal neovascularization
  • Total lesion size of >12 disc areas (30.5-mm2; included blood, scars, and neovascularization) in the study eye

Patient Demographics

Baseline Characteristics Were Evenly Balanced Across All Treatment Groups in the 2 Clinical Trials5

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    IMPORTANT SAFETY INFORMATION
    +
    • 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

    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 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 12 weeks (3 months).
    • 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 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).

    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.

    777 Old Saw Mill River Road, Tarrytown, NY 10591
    US-LEA-1934(1)

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