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ARTICLE | Clinical News

Eylea meets in Phase III trial for macular edema

October 21, 2013 11:39 PM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said intravitreal Eylea aflibercept given every four weeks met the primary endpoint in a 183-patient Phase III trial to treat macular edema following branch retinal vein occlusion (BRVO). Eylea improved the proportion of patients whose best corrected visual acuity (BCVA) improved by 15 letters or greater from baseline to week 24 vs. standard of care laser treatment (53% vs. 27%, p<0.001). Eylea also met the secondary endpoint of improving mean BCVA from baseline to week 24 vs. laser treatment (17 vs. 6.9 letters, p<0.0001). Regeneron said it plans to submit an sBLA to FDA for Eylea to treat macular edema following BRVO "within the next several months." Partner Bayer AG (Xetra:BAYN), which has ex-U.S. rights to Eylea from Regeneron, could not be reached for its plans in the indication.

Eylea is approved in the U.S. and EU to treat wet age-related macular degeneration (AMD) and visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). The human fusion protein that binds all forms of VEGF-A and placental growth factor (PIGF) is also approved for wet AMD in Japan, Australia, Switzerland and some Latin American countries. Regeneron also plans to submit a separate sBLA to FDA for Eylea to treat diabetic macular edema (DME) this year. ...