BioCentury
ARTICLE | Clinical News

Eylea aflibercept ophthalmic solution: Additional Phase III data

February 23, 2015 8:00 AM UTC

Additional data from the NIH-sponsored Phase III Protocol T comparative effectiveness study in 660 DME patients showed that Eylea improved mean BCVA from baseline to week 52, the primary endpoint, by 13.3 letters vs. 9.7 letters for Avastin bevacizumab (p<0.001) and 11.2 letters for Lucentis ranibizumab (p=0.03). However, the improvement with Eylea was not clinically meaningful because the difference was driven by the eyes with worse visual acuity at baseline.

In patients with initial visual acuity letter score of 69-78 -- equivalent to about 20/32-20/40 vision -- Eylea improved mean BCVA by 8 letters, Avastin improved by 7.5 letters and Lucentis improved by 8.3 letters (p=not significant for each comparison). In patients with initial visual acuity letter score of <69 -- equivalent to about 20/50 vision or worse -- mean BCVA improved by 18.9 letters with Eylea, by 11.8 letters with Avastin and by 14.2 letters with Lucentis (Eylea to Avastin, p<0.001; Eylea to Lucentis, p=0.003; Avastin to Lucentis, p=0.21). There were no significant differences among the treatment arms in the rates of serious adverse events, hospitalization, death or major cardiovascular events reported. Data were published in The New England Journal of Medicine. Previously reported data from the trial showed that Eylea met the primary endpoint of a greater improvement in mean BCVA from baseline to week 52 vs. both Avastin and Lucentis (see BioCentury, Oct. 20, 2014). ...