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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).

Treatment Burden: Disease Information

Living With Wet AMD and DME Can Severely Impact Patients and How Much They Value Their Vision

Wet AMD and DME are leading causes of severe loss of sight—potentially causing wavy and blurry vision, blind spots, and blindness—and impact how important it is to patients to protect their vision.1-6

References: 1. National Eye Institute. Accessed March 16, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration 2. The Angiogenesis Foundation. Accessed March 16, 2023. http://www.scienceofdme.org/learn/ 3. Centers for Disease Control and Prevention. Accessed March 16, 2023. https://www.cdc.gov/visionhealth/basics/ced/fastfacts.htm 4. BrightFocus® Foundation. Accessed March 16, 2023. https://www.brightfocus.org/macular/article/age-related-macular-facts-figures 5. Sharma S et al. Br J Ophthalmol. 2003;87(3):259-261. 6. Brown GC et al. Arch Ophthalmol. 2000;118(1):47-51.

Wet AMD and DME Are Leading Causes of Vision Loss

Wet AMD

  • Wet AMD is an advanced stage of AMD that involves abnormal formation and growth of blood vessels under the retina and can rapidly progress to severe vision loss1
    1. AMD is a leading cause of vision loss in people aged 60 years and older1
  • An estimated 20 million people in the United States have some form of AMD2
    1. Approximately 200,000 new cases of Wet AMD are diagnosed each year in North America3

DME

  • Diabetic retinopathy (DR) is the most common diabetic eye disease caused by changes in the blood vessels of the retina4
  • DME can develop at any of the 4 stages of DR—mild, moderate, severe nonproliferative, and proliferative—though it is more common in advanced stages4
  • DME affects 11% of patients with diabetes with approximately 75,000 new cases diagnosed annually in the United States4,5
  • Severe vision loss or blindness may result if not treated in a timely manner4

AMD = age-related macular degeneration; DME = diabetic macular edema.

References: 1. National Eye Institute. Accessed March 16, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration 2. Rein DB et al. JAMA Ophthalmol. 2022;e224401. doi: 10.1001/jamaophthalmol.2022.4401 3. Business Wire. Accessed April 27, 2023. https://www.businesswire.com/news/home/20210407005578/en/Global-Wet-Age-Related-Macular-Degeneration-Wet-AMD-Epidemiology-Forecast-to-2030—ResearchAndMarkets.com 4. The Angiogenesis Foundation. Accessed March 16, 2023. http://www.scienceofdme.org/learn/ 5. Pershing S et al. Ann Intern Med. 2014;160(1):18-29.

Patients With Wet AMD and DR Value Their Vision

*Cross-sectional study of patients with DR (20/30 or worse vision in 1 eye; N=221) conducted in 2000-2001. Mean age was 63.5 years and the median expected lifespan was 10 years. Data regarding patient utilities and other information derived from chart reviews and standardized patient interviews. Visual information was obtained from charts after an ocular examination was performed, which included both Snellen and pinhole acuities.1

†Cross-sectional study of patients with Wet AMD (20/40 vision or worse in 1 eye; N=72). Mean age was 74.4 years; 67% were female, 33% were male. Each participant underwent a complete ophthalmoscopic exam and was asked questions regarding their quality of life. Utility values were measured in 5 groups according to the visual acuity in the better-seeing eye: 1 (20/20 to 20/25); 2 (20/30 to 20/50); 3 (20/60 to 20/100); 4 (20/200 to 20/400), and 5 (counting fingers to light perception) using the time trade-off and the standard gamble methods. For time trade-off, patients were asked how many additional years they expected to live and how many of those years (if any) they would trade in return for receiving a technology that would guarantee perfect vision in each eye.2

AMD = age-related macular degeneration; DR = diabetic retinopathy.

References: 1. Sharma S et al. Br J Ophthalmol. 2003;87(3):259-261. 2. Brown GC et al. Arch Ophthalmol. 2000;118(1):47-51.

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.

[XX/2023]
EHD.23.04.0368

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.

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