US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) today announced results from a study which show Eylea (aflibercept) is superior to Swiss drug major Roche's (ROG:SIX) rivals Avastin (bevacizumab; used off-label) and Lucentis (ranibizumab) for some patients with diabetic macular oedema (DME).
In the study, 660 patients were randomized to receive either Eylea 2mg, Avastin 1.25mg, or Lucentis 0.3mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24 week visit if: 1) the OCT central subfield thickness was greater than or equal to 250 microns or there was edema that was threatening the fovea and 2) the eye did not improve on OCT or visual acuity from the last two consecutive injections.
Eylea injection demonstrated significantly greater improvement on the primary endpoint of mean visual acuity letter score change at one year (Eylea +13 letters; Avastin +10; Lucentis +11). These differences were driven by patients with moderate or worse vision loss at the start of the trial (worse than 20/40); in these patients, Eylea showed a statistically significant 7-letter (approximately 1.5 lines on an eye chart) improvement over Avastin and a 5-letter (1 line on an eye chart) improvement over Lucentis (Eylea +19 letters; Avastin +12; Lucentis +14).
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