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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

DME

PHOTON: A Head-to-Head Trial in DME

EYLEA HD Patients Were Immediately Extended Following 3 Initial Monthly Injections1,2

  • A multicenter, randomized, double-masked, phase 2/3, head-to-head clinical trial of EYLEA HD vs EYLEA® (aflibercept) Injection 2 mg in patients with DME involving the center of the macula (N=658) who were treatment-naïve (56%) or previously treated (44%)
  • Patients had a mean age of 62.3 years (range: 24-90) and a mean visual acuity of 63 ETDRS letters at baseline (range: 24-79)
  • Patients were randomized in a 1:2:1 ratio into 1 of 3 treatment arms:
Dme 3treatments
  • The primary endpoint was the mean change from baseline in BCVA at week 48 as measured by the ETDRS letter score
  • In the EYLEA HD groups, patients could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria starting at week 16
Study Dosing Parameters

Planned Dosing Schedules Through Week 482

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Dose Regimen Modification (DRM) Criteria for Interval Shortening in the EYLEA HD Groups2

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EYLEA HD Delivered Rapid and Durable Vision Gains With Longer
Treatment Intervals in DME

Mean Change in BCVA (ETDRS letters) From Baseline up to Week 481,2*

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EYLEA HD met the primary endpoint of noninferiority vs EYLEA at week 48. Both EYLEA HD treatments, Q16W and Q12W, were shown to be noninferior and clinically equivalent to EYLEA 2 mg Q8W with respect to the mean change in BCVA at week 48 using a prespecified noninferiority margin of 4 ETDRS letters. Differences in LS means at week 48 were -1.4 (95% CI, -3.3 to 0.4) and -0.6 (95% CI, -2.3 to 1.1) for Q16W and Q12W vs EYLEA 2 mg, respectively.1

* Following 3 initial monthly doses in the EYLEA HD groups and 5 in the EYLEA 2 mg group. FAS at baseline. FAS; observed values (censoring data post ICE) at week 48: EYLEA HD Q16W (n=149), EYLEA HD Q12W (n=277), EYLEA 2 mg Q8W (n=150).1
Early Reductions in CRT Maintained Through Week 48 With EYLEA HD

Mean Change in CRT From Baseline Through Week 48 (additional secondary endpoint)2,3*

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* Data limitations: Mean change in CRT from baseline at week 48 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 initial monthly doses in the EYLEA HD groups and 5 in the EYLEA 2 mg group. Reductions in CRT were determined by a central reading center on OCT. FAS at baseline. FAS; observed values (censoring data post ICE) at week 48: EYLEA HD Q16W (n=149), EYLEA HD Q12W (n=276), EYLEA 2 mg Q8W (n=148).2,4
‡ Patients who completed week 48: EYLEA HD Q16W (n=155), EYLEA HD Q12W (n=298), EYLEA 2 mg Q8W (n=156).1
EYLEA HD Demonstrated Durability With BCVA and CRT Improvements Achieved With Extended Dosing Intervals2,3

Proportion of Patients Maintaining Randomized Q16W and Q12W Dosing Intervals Through Week 482,3*

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* Following 3 initial monthly doses.1
† Patients completing week 48.2
‡ Patients who met DRM criteria for interval shortening.3
Demonstrated Safety Profile Consistent With EYLEA 2 mg1,5

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Adverse drug reactions (ADRs) reported in <1% of participants treated with EYLEA HD were ocular hyperemia (includes adverse events of conjunctival hyperemia, conjunctival irritation, ocular hyperemia), lacrimation increased, eyelid edema, hypersensitivity (includes adverse events of rash, urticaria, pruritus), retinal tear, and injection site hemorrhage.1

* Represents grouping of related terms.

IMPORTANT SAFETY INFORMATION AND INDICATIONS 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 to 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 have been seen within 60 minutes of intravitreal injection, including with EYLEA HD and 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 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 thromboembolic events in the wet AMD study (PULSAR) 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 (PHOTON) 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.
    • EYLEA: 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:

  • EYLEA HD:
    • The most common adverse reactions (≥3%) reported in patients receiving EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
  • 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 is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

EYLEA® (aflibercept) Injection 2 mg 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 full Prescribing Information for EYLEA HD and EYLEA.

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BCVA = best corrected visual acuity; CRT = central retinal thickness; DME = diabetic macular edema; ETDRS = Early Treatment Diabetic Retinopathy Study; FAS = full analysis set; ICE = intercurrent events; LS = least squares; OCT = optical coherence tomography; Q8W = every 8 weeks; Q12W = every 12 weeks; Q16W = every 16 weeks.

References: 1. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. October 2024. 2. Brown DM et al; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024;403(10432):1153-1163. 3. Boyer D; PHOTON Study Investigators. Presented at: Angiogenesis, Exudation, and Degeneration 2023; February 10-11, 2023. 4. Data on file. Regeneron Pharmaceuticals, Inc. 5. EYLEA full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. October 2024.

07/2025
US.EHD.25.06.0037

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