VEGF Trap-Eye demonstrated a statistically significant improvement in visual acuity over 24 weeks compared to macular laser therapy in patients with diabetic macular edema (DME), said co-developers Regeneron Pharmaceuticals (Tarrytown, N.Y.) and Bayer Healthcare (Leuverkusen, Germany) in a joint press release.
In this study, visual acuity improvement was assessed by the mean number of letters gained over the initial 24 weeks of the study, the companies said. The double-masked, prospective, randomized, multi-center Phase II trial evaluated 219 patients with clinically significant DME with central macular involvement. The patients were randomized to five groups.
The control group was given macular laser therapy at week one, and these patients were eligible for repeat laser treatments, but these were available in limited frequency of no more than at 16-week intervals. A total of two groups received monthly doses of 0.5 or 2.0 mg VEGF Trap-Eye throughout the six-month dosing period, and two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks four and eight) followed through week 24 by either every eight-week dosing or “as needed” dosing with specific repeat dosing parameters. At week 24, the macular laser therapy group (N=44;1.7 treatments) had gained +2.5 letters; the VEGF Trap-Eye 0.5 mg monthly group (n=44; 5.6 injections) had gained +8.6 letters; the VEGF Trap-Eye 2 mg monthly group (N=44; 5.5 injections) had gained +11.4 letters; the group receiving VEGF Trap-Eye 2 mg every other month, following three monthly injections (N=42; 3.8 injections) gained +8.5 letters, and the group receiving VEGF Trap-Eye as needed following three monthly injections (N=45; 4.4 injections) gained +10.3 letters.
Regeneron said additional results will be available later this year.