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DIABETIC MACULAR OEDEMA

EYLEA 2 mg offers you and your eligible DMO patients the flexibility of treat-and-extend (T&E) dosing in Year 1
1

EYLEA 2 mg is indicated for adults for the treatment of visual impairment due to diabetic macular oedema (DMO).1

Fixed or T&E dosing with EYLEA 2 mg in Year 1

gives you flexibility to individualise treatment to your DMO patients’ needs1*

*After five initial monthly doses, the EYLEA 2 mg treatment interval is extended to 2 months. Based on the physician’s judgement of visual and/or anatomic outcomes, treatment interval can then be maintained at bimonthly dosing for the first year followed by T&E, or further extended up to 16 weeks using proactive T&E dosing.1 Please see the EYLEA 2 mg Summary of Product Characteristics for full details of the licensed posology.

 

With the right start, your DMO patients could look forward to rapid vision gains from baseline
2,3,5,6

VIVID and VISTA

The VIVID and VISTA studies demonstrated rapid vision gains from baseline with EYLEA 2 mg from the first dose, which increased with each loading dose.2,3,6

VIVID: mean change in BCVA through to Week 522,3

VIVID mean change in BCVA from baseline

Adapted from Korobelnik JF, et al. 2014 & Data on File. EYLED045.
Percentages shown on the figure are the percentage of the vision gain at Week 52 achieved at each timepoint.

VIOLET

A T&E regimen could help DMO patients maintain vision gains achieved from baseline long term, while minimising clinic and patient burden.4,8

VIOLET: mean change in BCVA from baseline4

VIOLET mean change in BCVA from baseline

Adapted from Sivaprasad S, et al. 2020.

Full analysis set; last observation carried forward.
*After 5 initial monthly loading doses.4

Protocol T

Protocol T demonstrated rapid vision gains from baseline, with patients gaining a mean of >2 lines of vision after 1 year of EYLEA 2 mg treatment5*

Protocol T: mean change in BCVA to Week 525

Protocol T mean change in BCVA from baseline

Adapted from Diabetic Retinopathy Clinical Research Network, 2015.

*The use of EYLEA 2 mg in Protocol T is not in accordance with the licensed posology for EYLEA 2 mg. Please see the EYLEA 2 mg Summary of Product Characteristics for details of the licensed posology.
†This dosing regimen was based on strict OCT and vision retreatment criteria, and therefore resulted in patients receiving a mean of 9.2 injections, which is similar to the administered number of doses in the EYLEA 2Q8 group in VIVID and VISTA.1,5

Bayer continues to partner with NHS services to help support your DMO patients. Bayer-sponsored real-world studies of EYLEA 2 mg in DMO:
  • APOLLON 202020: 147 patients, ≥ 12-month duration, France
  • DRAKO 202121: 507 patients, 2-year duration, UK

EYLEA 2 mg has an established safety profile from extensive clinical and real-world experience:
1,22,23

  • 3102 patients were studied in the safety population in the eight Phase III studies of EYLEA 2 mg across indications. Among those, 2,501 patients were treated with the recommended dose of 2 mg1
  • In these RCTs, serious adverse reactions related to the injection procedure have occurred in fewer than 1 in 1900 intravitreal injections with EYLEA 2 mg1
Dosing

Full details of proactive dosing in DMO1

MoA

Innovative molecular design and mechanism of action1,24–28

Safety

Established safety profile in DMO1

Abbreviations

AE, adverse event. BCVA, best-corrected visual acuity. BL, baseline. BSE, best-seeing eye. CI, confidence interval. CRT, central retinal thickness. DMO, diabetic macular oedema. DRSS, diabetic retinopathy severity scale. ETDRS, Early Treatment Diabetic Retinopathy Study. MoA, mechanism of action. NEI-VFQ-25, National Eye Institute Visual Function Questionnaire 25. OCT, optical coherence tomography. OR, odds ratio. PIGF, placental growth factor. PRN, pro re nata (as needed). Q4, every 4 weeks. QoL, quality of life. RCT, randomised controlled trial. SD, standard deviation. RVO, retinal vein occlusion. T&E, treat and extend. VA, visual acuity. VEGF, vascular endothelial growth factor. WSE, worse-seeing eye. 2Q4, 2 mg every 4 weeks. 2Q8, 2 mg every 8 weeks.

References

  1. EYLEA® 40 mg/mL Summary of Product Characteristics.
  2. Bayer. Data on File. EYLD045.
  3. Korobelnik J-F, et al. Ophthalmology 2014;121:2247–2254.
  4. Sivaprasad S, et al. A phase 3b, randomized study comparing three dosing regimens of intravitreal aflibercept for diabetic macular edema beyond the first year of treatment: outcomes from the 100-week VIOLET study. EURETINA 2020. 2–4 October 2020. Virtual.
  5. Diabetic Retinopathy Clinical Research Network. N Engl J Med 2015;372:1193–1203.
  6. Bayer. Data on File. EYLD044.
  7. Heier JS, et al. Ophthalmology 2016;123:2376–2385.
  8. Garweg J, et al. Presented at EURETINA 2019. 5–8 September 2019. Paris, France.
  9. ClinicalTrials.gov. Efficacy and safety of three different aflibercept regimens in subjects with diabetic macular edema (DME) (VIOLET). Available at: https://clinicaltrials.gov/ct2/show/NCT02818998. Accessed: September 2024.
  10.  ClinicalTrials.gov. Investigation of the change of vision-related quality of life in subjects treated with aflibercept according to EU label for DME (AQUA). Available at: https://clinicaltrials.gov/ct2/show/NCT02581995. Accessed: September 2024.
  11.  Diabetic Retinopathy Clinical Research Network. N Engl J Med 2015;372:1193–1203. Supplementary appendix.
  12.  Lukic M, et al. Eur J Ophthalmol 2021;31:1201–1207.
  13.  Davidson JA, et al. Endocrine 2007;32:107–116.
  14.  Globe DR, et al. Ophthalmology 2004;111:1141–1149.
  15.  GOV.UK. Driving eyesight rules. Available at: https://www.gov.uk/driving-eyesight-rules. Accessed: September 2024.
  16.  The impact of vision loss. In: National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Public Health Approaches to Reduce Vision Impairment and Promote Eye Health; Teutsch SM, et al. (eds). Making eye health a population health imperative: vision for tomorrow. Washington (DC): National Academies Press (US); 2016 Sep 15. Available at: https://www.ncbi.nlm.nih.gov/books/NBK402367/. Accessed: September 2024.
  17.  Christ SL, et al. JAMA Ophthalmol 2014;132:1400–1406.
  18.  Barzey V, et al. Relationship between visual acuity and ability to perform activities in patients with diabetic macular edema. ESASO Retina Academy. 22–24 October 2015. Barcelona, Spain. Poster/abstract: 67.
  19.  Wells JA, et al. Ophthalmology 2016;123:1351–1359.
  20.  Korobelnik J-F, et al. Graefes Arch Clin Exp Ophthalmol 2020;258:521–528.
  21.  Sivaprasad S, et al. Eye (Lond) 2022;36:64–71.
  22.  Bayer. Data on File. EYLO015.
  23.  Bayer. Data on File. EYLO020.
  24.  Fauser S & Muether PS. Br J Ophthalmol 2016;100:1494–1498.
  25.  EMA. EYLEA EPAR assessment report 2012. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/eylea. Accessed: September 2024.
  26.  Papadopoulos N, et al. Angiogenesis 2012;15:171–185.
  27.  Kanda A, et al. Sci Rep 2015;5:17946.
  28.  Amadio M, et al. Pharmacol Res 2016;103:253–269.

PP-EYL-GB-2343 | September 2024

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