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

PANORAMA is the first phase 3 anti–VEGF trial specifically designed to study patients with moderately severe to severe NPDR without DME

PANORAMA Efficacy Outcomes at 24 and 52 Weeks (primary endpoints) and 100 Weeks (prespecified exploratory endpoint*): Proportion of Patients Achieving a ≥2-Step Improvement in ETDRS-DRSS^† Score From Baseline^1,2,‡

Graph showing proportion of patients achieving a ≥2-step improvement on the ETDRS-DRSS from baseline. Week 24: EYLEA 58% vs Sham 6%, Week 52: EYLEA 80% vs Sham 15%.

PANORAMA study design: Multicenter, double-masked, controlled clinical study in which patients with moderately severe to severe NPDR (ETDRS-DRSS: 47 or 53) without central-involved DME (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.

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 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, efficacy endpoints included the mean change from baseline in best-corrected visual acuity, as measured by ETDRS letter score, at 52 weeks (primary endpoint) and 100 weeks (secondary endpoint). The percentage of patients with a ≥2-step improvement on the ETDRS-DRSS (an established grading scale for measuring the severity of DR) from baseline at 100 weeks was 38%, 38%, and 16% in VISTA and 32%, 28%, and 7% in VIVID with EYLEA 2 mg every 8 weeks after 5 initial monthly doses, EYLEA 2 mg every 4 weeks, and control, respectively (secondary endpoint).

anti-VEGF = anti–vascular endothelial growth factor.
*The results of these exploratory endpoints require cautious interpretation, as a multiplicity adjustment has not been applied. Results are descriptive only.
^†Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.
^‡Full analysis set.

DR Patients Were Randomly Assigned 1:1:1 to 1 of 3 Treatment Regimens^1,2

	Baseline Through Week 96
EYLEA 2 mg every 16 weeks	3 monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks
EYLEA 2 mg every 8 weeks	5 monthly injections, followed by 1 injection every 8 weeks through week 52. After week 52, patients were switched to a diﬀerent dosing regimen through week 96
sham	sham treatment

Patients were randomly assigned one of three treatment regimens: 1. EYLEA 2 mg every 16 weeks 2. EYLEA 2 mg every 8 weeks 3. Sham Treatment.

Recommended Dosing

The recommended dose for EYLEA in DR is 2 mg (0.05 mL) 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

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

Power Against Disease Progression

EYLEA helps prevent DR vision–threatening complications that can lead to blindness.^1,2

Fewer patients with moderately severe to severe NPDR progressed to proliferative DR (PDR) or anterior segment neovascularization (ASNV) or developed central–involved DME (CI–DME) vs sham through weeks 52 and 100 in the clinical PANORAMA study^1,2

Progression to PDR or ASNV or Development of CI–DME Through Weeks 52 and 100^1,2,*^,†

Chart showing the % patients with disease progression to PDR or ASNV or development of CI-DME through week 52, as well as the relative risk reduction with EYLEA treatment.

Start with EYLEA to help stop progression to PDR/ASNV or development of CI-DME^1,2

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

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

EYLEA 2 mg every 8 weeks^§: 0% (hazard ratio: 0.00)
EYLEA 2 mg every 16 weeks^§: 1.6% (hazard ratio: 0.11)
sham: 11.9%

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

EYLEA 2 mg every 16 weeks^§: 4.5% (hazard ratio: 0.18)
sham: 20.2%

*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.

Anatomic Outcomes at 52 and 100 Weeks²

EYLEA patients had reductions in central retinal thickness²

Mean Change in Central Retinal Thickness, as Measured by OCT,* From Baseline at 52 and 100 Weeks (exploratory endpoints)^2,†

Graph showing reductions in central retinal thickness at 52 weeks.

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

*Optical coherence tomography.
^†Last observation carried forward; full analysis set.
^§EYLEA treatment groups: 3 initial monthly injections, followed by 1 injection after 8 weeks and then 1 injection every 16 weeks.

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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.

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.

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DR: ANATOMY OUTCOMES