Diabetic Retinal Disease: A Growing Epidemic

According to 2018 estimates from the CDC

In 2018, diabetes was the seventh leading cause of death in the United States.²

Diabetic Retinopathy Is Considered a Common, Serious, and Undertreated
Complication of Diabetes^3-6

*Adults aged 20 to 74 years.

CDC, Centers for Disease Control and Prevention.

DR Disease Severity Can Progress Quickly and at Any Time

Natural course rate of progression to PDR in 1 year⁷

Natural course rate of progression to PDR in 1 year: Severe or very severe NPDR (52%), Moderate NPDR (12%), Mild NPDR (5%).

NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy.

Diabetic Macular Edema Is a Complication of DR⁵

Approximately half of all patients diagnosed with DR are expected to develop DME⁵

More than 30% of untreated patients with DME can progress to moderate vision loss within 3 years⁸
Risk of DME increases with the severity of DR⁹

DME Can Develop at Any Stage of DR Severity

Cumulative incidence of DME by baseline NPDR severity in anti-VEGF–naïve eyes over 4 years⁹

Cumulative incidence of DME by baseline NPDR severity in anti-VEGF naive eyes over 4 years. Severe NPDR: 44% - Baseline (n=10,962), Year 2 (n=1585), Year 4 (n=377). Moderate NPDR: 34% - baseline (n=39,116), Year 2 (n=7562), Year 4 (n=2191). Mild NPDR: 21% - Baseline (n=70,050), Year 2 (n=14,003), Year 4 (n=4138). Unspecified NPDR: 15% - Baseline (n=15,466), Year 2 (n=5608), Year (n=2700)

anti-VEGF, anti–vascular endothelial growth factor; NPDR, nonproliferative diabetic retinopathy.

Risk of Developing Vision-Threatening Complications

Proportion of patients with moderately severe to severe NPDR who
progressed to PDR, ASNV, or CI-DME at Years 1 and 2 from baseline¹⁰

anti-VEGF, anti–vascular endothelial growth factor; NPDR, nonproliferative diabetic retinopathy.

Awareness Is Limited Among Patients With Diabetic Retinal Disease

Cross-sectional analysis of 2005-2008 National Health and Nutrition Examination Survey (NHANES) data; N=798 participants with self-reported diabetes stratified by DR and DME status.¹²

DR Severity Scale (DRSS)

Useful for staging the disease and allowing for proper diagnosis and timely intervention with a goal to help prevent or reverse disease
progression^13-16
Evaluation of disease by fundus examination: Fundus photography is typically more sensitive in detecting DR lesions than other imaging methods used in practice¹⁷

DR severity scores are based on extent and severity of the disease signs.

DRSS

Mild NPDR

Moderate NPDR

Moderately
Severe NPDR

Severe NPDR

PDR

Images courtesy of Dr. Mohammad Rafieetary. Used with permission. Images were captured at different visits.
Scale is adapted from the ETDRS-DRSS, an established grading scale for measuring the severity of DR, as well as the AAO.

*The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.

AAO, American Academy of Ophthalmology; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy.

Example of a 2-Step Improvement on the DRSS*

*Adapted from the AAO and ETDRS-DRSS.

^†The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.

AAO, American Academy of Ophthalmology; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; NPDR, nonproliferative
diabetic retinopathy; PDR, proliferative diabetic retinopathy.

DR severity data
with EYLEA¹⁸

Dosing flexibility with
EYLEA in DR¹⁸

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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.
Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

References

National Diabetes Statistics Report, 2020: estimates of diabetes and its burden in the United States. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://
www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
Centers for Disease Control and Prevention. Underlying Cause of Death 1999-2018. Data are from the Multiple Cause of Death Files, 1999-2018, as compiled from data provided by the
57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed November 5, 2020. http://wonder.cdc.gov/ucd-icd10.html
Common eye disorders. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://www.cdc.gov/visionhealth/basics/ced/index.html
Diabetic retinopathy. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://www.cdc.gov/visionhealth/pdf/factsheet.pdf
Diabetic retinopathy. National Eye Institute, National Institutes of Health. Accessed November 5, 2020. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/
diabetic-retinopathy
Diabetic retinopathy data and statistics. National Eye Institute, National Institutes of Health. Accessed November 5, 2020. https://www.nei.nih.gov/learn-about-eye-health/resources-
for-health-educators/eye-health-data-and-statistics/diabetic-retinopathy-data-and-statistics
Eye care of the patient with diabetes mellitus. American Optometric Association. Accessed November 5, 2020. http://aoa.uberflip.com/i/1183026-evidence-based-clinical-practice-guideline-eye-care-of-the-patient-with-diabetes-mellitus-second-edition/0?m4=
Gangnon RE, Davis MD, Hubbard LD, et al. A severity scale for diabetic macular edema developed from ETDRS data. Invest Ophthalmol Vis Sci. 2008;49(11):5041-5047. doi:10.1167/
iovs.08-2231
Moshfeghi AA. Natural history of disease progression in nonproliferative diabetic retinopathy (NPDR) patients in the US. Data presented at: Macula Society 2020 Meeting; February
20, 2020; San Diego, CA.
Wykoff CC. Intravitreal aflibercept for moderately severe to severe non-proliferative diabetic retinopathy (NPDR): 2-year outcomes of the phase 3 PANORAMA study. Data presented
at: Angiogenesis, Exudation, and Degeneration Annual Meeting; February 8, 2020; Miami, FL.
Holekamp NM. Overview of diabetic macular edema. Am J Manag Care. 2016;22(suppl 10):s284-s291.
Bressler NM, Varma R, Doan QV. Underuse of the health care system by persons with diabetes mellitus and diabetic macular edema in the United States. JAMA Ophthalmol. 2014;132(2):168-173. doi:10.1001/jamaophthalmol.2013.6426
American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. Accessed November 5, 2020. https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp
Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Ophthalmology. 1991;98(suppl 5):823-833.
Davis MD, Fisher MR, Gangnon RE, et al. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study Report #18.
Invest Ophthalmol Vis Sci. 1998;39(2):233-252.
Staurenghi G, Feltgen N, Arnold JJ, et al; for the VIVID-DME and VISTA-DME Study Investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in
the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018;102(7):954-958. doi:10.1136/bjophthalmol-2017-310664
Gangaputra S, Lovato JF, Hubbard L, et al; for the ACCORD Eye Research Group. Comparison of standardized clinical classification with fundus photograph grading for the
assessment of diabetic retinopathy and diabetic macular edema severity. Retina. 2013;33(7):1393-1399. doi:10.1097/IAE.0b013e318286c952
EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021.

DR: DISEASE EDUCATION