FEB 12, 2014
Regeneron Pharmaceuticals this week reported positive two-year results from a phase 3 trial comparing aflibercept (Eylea) with laser photocoagulation for diabetic macular edema (DME).
Patients enrolled in the VISTA-DME trial were randomized to 2 mg of aflibercept injected monthly, 2 mg of aflibercept dosed every two months (after five initial monthly injections) or laser photocoagulation.
Both treatment arms achieved the study’s primary endpoint of a significantly greater improvement in BCVA from baseline compared with laser photocoagulation after two years and demonstrated similar improvements in BCVA.
After two years, patients dosed monthly had a mean BCVA change from baseline of 11.5 letters, while patients dosed every two months had a mean change of 11.1 letters. Patients treated with laser experienced a mean change of 0.9 letters.
“These results are particularly encouraging given that 43 percent of patients in this study had previously received anti-VEGF therapy,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories.
Aflibercept was generally well tolerated. Adverse events were typical of those seen in other studies of patients with diabetes who received intravitreal anti-VEGF therapy, with conjunctival hemorrhage, eye pain and vitreous floaters as the most frequent ocular adverse events observed.