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Intended for use by payers, formulary committees, or other similar entities for purposes of population-based drug
selection, coverage, and/or reimbursement decision making, pursuant to FD&C Act Section 502(a).
Prescribing Information
EYLEA HD EYLEA

MEfRVO

QUASAR: A Head-to-Head Trial in MEfRVO

Proven Vision Gains in EYLEA HD–Treated Patients With Q8W Dosing After Initial Monthly Dosing1-3

  • Randomized, multicenter, double-masked, phase 3, clinical study of EYLEA HD vs EYLEA® (aflibercept) Injection 2 mg in treatment-naïve patients with MEfRVO (N=892 [425 with CRVO/HRVO, 467 with BRVO])
  • Patients had a mean age of 65.9 years (range: 23-95) and a mean visual acuity of ≈55 ETDRS letters at baseline (range: 18-74)
  • Patients were randomized in a 1:1:1 ratio into 1 of 3 treatment arms:
Rvo chart1 v2
Mefrvo chart1 mob
  • The primary endpoint was the mean change from baseline in BCVA at week 36 as measured by the ETDRS letter score
  • Intervals could be shortened beginning at week 16 for the EYLEA HD Q8W/3 group, at week 24 for the EYLEA HD Q8W/5 group and, if previously extended, at week 40 for the EYLEA 2 mg Q4W group
  • Intervals could be extended beginning at week 32 for the EYLEA HD Q8W/3 and EYLEA 2 mg Q4W groups and at week 40 for the EYLEA HD Q8W/5 group
  • Dosing intervals could be shortened or extended by 4-week increments based on protocol-defined visual and anatomic criteria, with a minimum interval of Q4W for all patients
Study Dosing Parameters

Planned Dosing Schedule Through Week 363

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Dosing intervals could be shortened or extended by 4-week increments based on protocol-defined visual and anatomic criteria, with a minimum interval of Q4W for all patients.

* Active injection for participants meeting DRM criteria at week 16.3
† Active injection for participants meeting DRM criteria at week 16 or 24.3

Dosing Flexibility Allowed Patient Dosing Intervals to Be Shortened Based on Clinical Response1,3,4

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‡ Reference visit was week 12 for the EYLEA HD Q8W/3 group and week 20 for the EYLEA HD Q8W/5 and EYLEA 2 mg Q4W groups.3
Rapid and Sustained Vision Gains With EYLEA HD

Mean Change in BCVA (ETDRS letters) From Baseline Through Week 361,2

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EYLEA HD met the primary endpoint of noninferiority vs EYLEA at week 36. Both EYLEA HD groups, Q8W/3 and Q8W/5, were shown to be noninferior and clinically equivalent to EYLEA 2 mg Q4W with respect to the mean change in BCVA at week 36 using a prespecified noninferiority margin of 4 ETDRS letters. Differences in LS means at week 36 were -0.1 (95% CI, -2.0 to +1.9) and 0.8 (95% CI, -1.1 to +2.7) for Q8W/3 and Q8W/5 vs EYLEA 2mg, respectively.1

* Following 3 and 5 initial monthly doses in the EYLEA HD Q8W/3 and Q8W/5 groups, respectively. FAS at baseline. FAS; observed values (censoring data post ICE) at week 36: EYLEA HD Q8W/3 (n=260), EYLEA HD Q8W/5 (n=248), EYLEA 2 mg Q4W (n=264).1,2
† FAS: EYLEA HD Q8W/3 (n=293), EYLEA HD Q8W/5 (n=298), EYLEA 2 mg Q4W (n=301).3

Proportion of Patients Gaining ≥15 ETDRS Letters in BCVA From Baseline at Week 363,4*†

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* Data limitations: The proportion of patients gaining ≥15 ETDRS letters in BCVA from baseline at week 36 was a prespecified additional secondary endpoint. This endpoint was analyzed descriptively only and not adjusted for multiplicity. Clinical significance has not been established and conclusions regarding treatment effect cannot be drawn.
† Observed values (censoring data post ICE).3
Rapid Reductions in CRT Maintained Through Week 36 With EYLEA HD

Mean Change in CRT From Baseline Through Week 36 (additional secondary endpoint)2,3*

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* Data limitations: Mean change in CRT at week 36 was a prespecified additional secondary endpoint. This endpoint was analyzed descriptively only and not adjusted for multiplicity. Clinical significance has not been established and conclusions regarding treatment effect cannot be drawn.
† Following 3 and 5 initial monthly doses in the EYLEA HD Q8W/3 and Q8W/5 groups, respectively. FAS at baseline. FAS; observed values (censoring data post ICE) at week 36: EYLEA HD Q8W/3 (n=260), EYLEA HD Q8W/5 (n=247), EYLEA 2 mg Q4W (n=262).1,2
‡ FAS: EYLEA HD Q8W/3 (n=293), EYLEA HD Q8W/5 (n=298), EYLEA 2 mg Q4W (n=301).3
Majority of EYLEA HD Patients Maintained Q8W Dosing Through Week 363

Proportion of Patients in the EYLEA HD Groups Maintaining Randomized Q8W Dosing Intervals Through Week 363*†

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* Following 3 or 5 initial monthly doses.3
† 9.1% of total EYLEA HD–treated patients met protocol-defined criteria to be treated every 4 weeks.1
‡ Patients who met DRM criteria for interval shortening.3
§ Patients completing week 36: EYLEA HD Q8W/3 (n=278), EYLEA HD Q8W/5 (n=273), EYLEA 2 mg Q4W (n=287).3
Values do not total 100% due to rounding.
Demonstrated Safety Profile Consistent With EYLEA 2 mg1,5

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Adverse reactions reported in <1% of the patients treated with EYLEA HD in the RVO study were foreign body sensation in eyes (includes foreign body sensation in eyes and sensation of foreign body), ocular hyperemia (includes conjunctival hyperemia, conjunctival irritation, ocular hyperemia), retinal hemorrhage, retinal pigment epithelial detachment (includes detachment of retinal pigment epithelium), retinal pigment epithelial tear/epitheliopathy (includes retinal pigment epitheliopathy), and retinal tear.1

  • There was one case of endophthalmitis in the EYLEA HD Q8W/3 group and 2 cases in the EYLEA 2 mg group3
  • No cases of occlusive retinal vasculitis were reported3
No new safety signals for aflibercept were reported in the QUASAR trial3
* Represents grouping of related terms.1
† Represents reported nonocular adverse events of hypersensitivity, rash, urticaria, and pruritus.1

IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA

CONTRAINDICATIONS

  • EYLEA HD and EYLEA are contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in EYLEA HD or EYLEA.

WARNINGS AND PRECAUTIONS

  • Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering EYLEA HD or EYLEA. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
  • Acute increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with EYLEA HD and EYLEA. Sustained increases in IOP have also been reported after repeated intravitreal dosing with VEGF inhibitors. IOP 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 HD and EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
    • EYLEA HD: The incidence of reported ATEs in the Wet AMD study from baseline through week 48 was 0.4% (3 out of 673) in the combined group of patients treated with EYLEA HD compared with 1.5% (5 out of 336) in patients treated with EYLEA 2 mg. The incidence in the DME study from baseline to week 48 was 3.1% (15 out of 491) in the combined group of patients treated with EYLEA HD compared with 3.6% (6 out of 167) in patients treated with EYLEA 2 mg. The incidence in the RVO study from baseline to week 36 was 0.5% (3 out of 591) in the combined group of patients treated with EYLEA HD compared with 1.7% (5 out of 301) in patients treated with EYLEA 2 mg.
    • EYLEA: The incidence of reported ATEs 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

  • EYLEA HD: The most common adverse reactions (≥3%) reported in patients receiving EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters.
  • EYLEA: 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.
  • Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD or EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

INDICATIONS

EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injection 2 mg are indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema following Retinal Vein Occlusion (RVO).

Please click here for full Prescribing Information for EYLEA HD and EYLEA.

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BCVA = best corrected visual acuity; BRVO = branch retinal vein occlusion; CRT = central retinal thickness; CRVO = central retinal vein occlusion; DRM = dose regimen modification; ETDRS = Early Treatment Diabetic Retinopathy Study; FAS = full analysis set; HRVO = hemiretinal vein occlusion; ICE = intercurrent events; LS = least squares; MEfRVO = macular edema following retinal vein occlusion; Q4W = every 4 weeks; Q8W = every 8 weeks; Q8W/3 = every 8 weeks after 3 initial monthly injections; Q8W/5 = every 8 weeks after 5 initial monthly injections; RVO = retinal vein occlusion.

References: 1. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. November 2025. 2. Data on file. Regeneron Pharmaceuticals, Inc. 3. Gale R; QUASAR Group. Aflibercept 8 mg in retinal vein occlusion: primary endpoint results from the QUASAR trial. Presented at: Angiogenesis Meeting 2025; February 8, 2025; virtual. 4. Fein JG; QUASAR Study Investigators. Aflibercept 8 mg in treatment-naive macular edema secondary to retinal vein occlusion: primary endpoint results from the QUASAR study. Presented at: Retina World Congress 2025; May 8-11, 2025; virtual. 5. EYLEA full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. October 2024.

11/2025
US.EHD.25.07.0171

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