s Eylea » Clinical Trial Results

OUR DATA: The Efficacy and Safety of EYLEA® (aflibercept) Injection Were Demonstrated in the Largest Anti–Vascular Endothelial Growth Factor (Anti-VEGF) Diabetic Macular Edema (DME) Clinical Trial Program to Date1

Largest Anti-VEGF phase 3 clinical trials for DME treatment to date1

The efficacy of EYLEA was demonstrated in 2 randomized, multicenter, double-masked, controlled trials involving 872 patients with DME.

VISTA and VIVID Clinical Trials

PIVOTAL TRIALS: Superior Improvement of Mean Change
in BCVA* at 52 and 100 Weeks vs Control

EYLEA Demonstrated a Statistically Superior Improvement of Mean Change in Visual Acuity From Baseline
at 52 and 100 Weeks vs Control in the 2 Clinical Phase 3 Trials of 862 Patients

*Best-corrected visual acuity, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

  • Improvements in BCVA were seen as early as 4 weeks

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) 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.

OUR DATA: Treatment Effects by Baseline Visual Acuity
Subgroups Were Consistent With The Results of The
Overall Population

Approximately Half of Patients Newly Diagnosed With DME Present With Visual Acuity of Worse Than 20/403
  • Similar results were seen at 100 weeks in VIVID4

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) 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.

THEIR VISION: Significant, Clinically Meaningful Vision
Improvement vs Control

A Greater Proportion of Patients Treated With EYLEA Had Improved Vision vs Control, as Measured by
≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Gained at 100 Weeks

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) 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.

THEIR VISION: Similar Results in Visual Acuity Improvements
With or Without Prior Anti-VEGF Treatment*

EYLEA Patients Who Received Prior Anti-VEGF Treatment Had Generally Consistent Visual Acuity Outcomes at 100 Weeks vs Patients Naîve to Anti-VEGF Treatment4

*Prior anti-VEGF treatment included ranibizumab, bevacizumab, and/or pegaptanib,4 and a ≥3-month washout period was required before enrollment into either study.2

  • 42.9% of patients in VISTA and 8.9% of patients in VIVID received prior anti-VEGF treatment and were enrolled following a washout period of ≥ 3 months2

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) 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.

THEIR VISION: EYLEA Demonstrated Improvement in DR*
at 100 Weeks vs Control

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) 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.

OUR SAFETY PROFILE: Demonstrated Safety Profile
in the Clinical Trials

  • Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema and injection-site hemorrhage
EYLEA Requires No Dose Adjustment in Geriatric Patients* or in Patients With Renal Impairment3, †
  • No significant differences in efficacy or safety were seen with increasing age in all of the EYLEA clinical trials

*In all of the EYLEA 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: Overall Incidence of APTC (Antiplatelet
Trialists' Collaboration)-Defined Arterial Thromboembolic
Events* Across All treatment Groups in the 2 Clinical Phase 3 Trials4,†

*APTC-defined arterial thromboembolic events included nonfatal myocardial infarction, nonfatal stroke, and vascular death, as adjudicated by a masked committee.
Safety analysis set.

No Increase in Mean Blood Pressure Was Observed Through 100 Weeks
  • In an integrated, prespecified analysis of the treatment groups in the VISTA and VIVID trials4
  • Change in blood pressure is a sensitive biomarker of systemic anti-VEGF activity5-8
  • As observed in the VISTA and VIVID trials, hypertension was reported as an adverse event in 24.4% of patients in the control group and 22.5% of patients in the combined EYLEA groups and as a serious adverse event in 1.0% of patients in the control group and 1.2% of patients in the combined EYLEA groups4

VISTA and VIVID Study Designs

Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862) were randomized and received 1) EYLEA® (aflibercept) Injection 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.

Primary Endpoint
  • Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline
Secondary Endpoints2
  • % patients gaining ≥15 ETDRS letters at 52 weeks from baseline vs control
  • % patients achieving ≥ 2-step improvement in the ETDRS-DRSS at 100 weeks

Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.

Study Entry Criteria

Patient Disposition2

Inclusion criteria2

  • Adults aged ≥18 years with type 1 or 2 diabetes with DME involving the central subfield
  • ETDRS BCVA 20/40 to 20/320

Patients Who Received Prior Anti-VEGF Treatment Were Enrolled in the 2 Clinical Trials2

  • 42.9% of patients in VISTA and 8.9% of patients in VIVID received prior anti-VEGF treatment and were enrolled following a washout period of ≥3 months

Exclusion criteria (select)2

  • No laser or anti-VEGF therapy in the study eye within the last 3 months or use of corticosteroids in the study eye within the last 4 months
  • Active proliferative diabetic retinopathy in the study eye
  • Intraocular pressure ≥25 mm Hg
  • No previous vitreoretinal surgery in the study eye
  • Uncontrolled diabetes (VISTA: opinion of the investigator; VIVID: hemoglobin A1c [HbA1c] >12%)
  • Uncontrolled blood pressure (systolic >160 mm Hg or diastolic >95 mm Hg while sitting)
  • History of cerebrovascular accident or myocardial infarction within the last 6 months

Patient Demographics

Baseline Demographics in the 2 Clinical Trials2

    Coming Soon

    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
    * Following 3 initial monthly doses (every 4 weeks).

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

    777 Old Saw Mill River Road, Tarrytown, NY 10591
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