EYLEA® IS THE EURETINA GUIDELINES DME DRUG OF CHOICE IN PATIENTS WITH BASELINE BCVA <69 LETTERS5,6,a,b
2 mg EYLEA®
0.3 mg ranibizumab
125 mg bevacizumab
2 mg EYLEA®
0.3 mg ranibizumab
125 mg bevacizumab
VIVID: Mean change in BCVA through Week 52
EYLEA® 2 mg administered every month (4 weeks) for the first 5 months, followed by once every 2 months (n=135)
Laser photocoagulation administered as needed, no more often than every 12 weeks (n=132)
- In Protocol T, the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA® or ranibizumab. Return to content
- The EURETINA Guidelines included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA® or ranibizumab. Return to content
- Bevacizumab has no marketing authorization for use in ophthalmic indications. Return to content
- Meta-analysis using Cochrane methods (based on a search of databases conducted in April 2017) of RCTs with anti-VEGF agents in DME patients, focused on the three most commonly used drugs: EYLEA®, ranibizumab, and unlicensed bevacizumab. The analysis included 24 studies and 6007 participants in total. A total of 17 studies (4031 eyes) were assessed for gains of 3 or more VA lines at one year. This Cochrane meta-analysis included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage) while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA® or ranibizumab. Return to content
- Pairwise comparisons (adjusted for multiple comparisons) over 2 years: ranibizumab (52%) vs EYLEA® (41%; P=0.04) Return to content
- In the VIVID and VISTA RCTs patients were randomized to receive EYLEA® 2 mg either every 4 or 8 weeks after 5 monthly doses, or laser control. From Week 24, if rescue treatment criteria were met, EYLEA® patients received active laser, and laser control patients received 5 monthly doses of EYLEA®, followed by dosing every 8 weeks. From Week 100, laser control patients who had not received EYLEA® rescue treatment received EYLEA® as needed per retreatment criteria. Return to content
References:
- EYLEA® (aflibercept solution for injection) Summary of Product Characteristics. Berlin, Germany: Bayer Pharma AG. Return to content
- A Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121:2247-2254. Return to content
- Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123:1351-1359. Return to content
- Jampol LM, Glassman AR, Bressler NM, Wells JA, Ayala AR; for the Diabetic Retinopathy Clinical Research Network. Anti-vascular endothelial growth factor comparative effectiveness trial for diabetic macular edema: additional efficacy post hoc analyses of a randomized clinical trial. JAMA Ophthalmol. 2016;134:1429-1434. Return to content
- Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis (review).Cochrane Database Syst Rev. 2017;6:CD007419.pub5. Return to content
- Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237:185-22.pub5. Return to content
- Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372:1193-1203. Return to content
- Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID‑DME and VISTA‑DME data. Int J Retina Vitreous. 2016;2:16. Return to content
- Papadopoulos N, Martin J, Ruan Q, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap,ranibizumab and bevacizumab. Angiogenesis. 2012;15;171-185. Return to content
- Krizova L, Kalousova M, Kubena AA, et al. Correlation of vitreous vascular endothelial growth factor and uric acid concentration using optical coherence tomography in diabetic macular edema. J Ophthalmol. 2015;478509. Return to content
- Al Kahtani E, Xu Z, Al Rashead S, et al. Vitreous levels of placental growth factor correlate with activity of proliferative diabetic retinopathy and are not influenced by bevacizumab treatment. Eye (Lond). 2017;31:529-536. Return to content
- Nguyen QD, De Falco S, Behar-Cohen F, et al. Placental growth factor and its potential role in diabetic retinopathy and other ocular neovascular diseases. Acta Ophthalmol. 2018;96:e1-e9. Return to content
- Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies.Ophthalmology. 2016;123:2376-2385. Return to content
- Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122:2044-2052. Return to content
