FEB 05, 2015
A committee of the European Medicines Agency recommends the expanded use of aflibercept for macular edema secondary to branch retinal vein occlusion (BRVO).
Aflibercept is already approved in Europe for central retinal vein occlusion (CRVO) and wet AMD. In the United States, it is approved for BRVO, CRVO, wet AMD and diabetic macular edema.
The recommendation is based on previous approval of aflibercept for macular edema due to CRVO and on positive results from a double-masked, randomized, controlled phase 3 study.
The 52-week study included 181 patients and compared treatment with aflibercept 2 mg once every 4 weeks with macular laser photocoagulation. At 24 weeks, significantly more patients treated with aflibercept gained at least 15 letters in vision compared with the laser group (53 percent vs. 27 percent; P < 0.01), and achieved a greater improvement in baseline BCVA (17.0 vs. 6.9 letter mean improvement; P < 0.01).