Eylea success in DME Trials

In the Phase III VIVID-DME and VISTA-DME trials of Eylea (VEGF Trap-Eye) from Regeneron and Bayer, for the treatment of Diabetic Macular Oedema (DME), VEGF Trap-Eye 2 milligrams (mg) dosed monthly and VEGF Trap-Eye 2 mg dosed every two months (after 5 initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. Both VEGF Trap-Eye treatment arms demonstrated similar improvements in BCVA (Best Corrected Visual Acuity).

In the VIVID-DME trial, after one year patients receiving VEGF Trap-Eye 2 mg monthly had a mean change from baseline in best-corrected visual acuity (BCVA) of 10.5 letters (p<0.0001 compared to laser), patients receiving vegf trap-eye 2 mg every other month (after 5 initial monthly injections) had a mean change from baseline in bcva of 10.7 letters (p><0.0001 compared to laser), compared to patients receiving laser photocoagulation who had a mean change from baseline in bcva of 1.2 letters.>

In the VISTA-DME trial, after one year patients receiving VEGF Trap-Eye 2 mg monthly had a mean change from baseline in best-corrected visual acuity (BCVA) of 12.5 letters (p<0.0001 compared to laser), patients receiving vegf trap-eye 2 mg every other month (after 5 initial monthly injections) had a mean change from baseline in bcva of 10.7 letters (p><0.0001 compared to laser), compared to patients receiving laser photocoagulation who had a mean change from baseline in bcva of 0.2 letters.in these trials, vegf trap-eye was generally well tolerated with a similar overall incidence of adverse events (aes), ocular serious aes, and non-ocular serious aes across the treatment groups and the laser control group.>

Bayer and Regeneron plan to file at EMA and FDA for DME in 2013.