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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).

Effective April 1, 2024 EYLEA HD can be billed using the permanent J-code J0177

EYLEA HD Is FDA Approved

For the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR)1

  • The approval is supported by the outcomes of the PULSAR trial for Wet AMD and the PHOTON trial for DME and DR1
  • Extended dosing regimens: EYLEA HD is the first and only anti-VEGF treatment approved in Wet AMD and DME for immediate dosing at Q8W and up to Q16W intervals following 3 initial monthly doses1
    – Q8W to Q12W dosing regimens following 3 initial monthly doses are approved for patients with DR1
  • In the combined EYLEA HD Q12W and Q16W group, 83% of patients with Wet AMD in the PULSAR trial and 93% of patients with DME in the PHOTON trial maintained dosing intervals ≥Q12W through week 482,3*
    • – In the PULSAR and PHOTON trials, patients in the EYLEA HD Q12W and Q16W groups could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria, starting at week 161
    *Following 3 initial monthly doses. Pooled EYLEA HD Q12W and Q16W groups; patients who completed week 48: PULSAR (n=628); PHOTON (n=456).
Click on the topics below for more information.

Product Information

Product specifications
for EYLEA HD
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Wet AMD Data

PULSAR pivotal trial: Efficacy and safety results in patients with Wet AMD
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DME Data

PHOTON pivotal trial: Efficacy and safety results in patients with DME
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Estimated Costs

Estimated year 1 treatment costs for Wet AMD and DME
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Unmet Needs

Key unmet needs and impact on patients
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IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA (aflibercept) Injection 2 mg
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.

FDA = US Food and Drug Administration; Q8W = every 8 weeks; Q12W = every 12 weeks; Q16W = every 16 weeks; VEFG = vascular endothelial growth factor.

References: 1. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 2. Brown DM; PULSAR Study Investigators. Aflibercept 8 mg in patients with nAMD: 48-week results from the phase 3 PULSAR trial. Presented at: Angiogenesis, Exudation, and Degeneration 2023; February 11, 2023. 3. Boyer D; PHOTON Study Investigators. Intravitreal aflibercept injection 8mg for DME: 48-week results from the phase 2/3 PHOTON trial. Presented at: Angiogenesis, Exudation, and Degeneration 2023: February 10-11, 2023.

01/2024
US.EHD.23.12.0051

IMPORTANT SAFETY INFORMATION
AND INDICATIONS FOR EYLEA HD AND EYLEA (aflibercept) Injection 2 mg +

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.

Welcome to the Market Access Website for EYLEA HD

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