Berlin, February 26, 2015 – Bayer HealthCare announced today that EYLEA? (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO). This new indication includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion in adults (CRVO). The recommended treatment approach is to initiate therapy with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity. Treatment may then be continued with a “treat and extend” regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes.
“RVO is a chronic disease that requires early and ongoing management to obtain the best possible vision, which is critical as many patients are still of working-age,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This new therapeutic approach allows physicians to individualize therapy for each patient, maximizing time between treatments. This reduces the treatment burden on patients, physicians and their clinics."
The approval is based on positive results from the double-masked, randomized, active-controlled phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO. The primary endpoint was the proportion of subjects who gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. More than half of the patients who were treated with aflibercept solution for injection gained at least three lines of vision.
