Bayer’s Eylea wins approval in Europe to treat retinal vein occlusion

The new indication for Eylea 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 European approval is based on positive results from the double-masked, randomized, active-controlled Phase III VIBRANT trial in patients with visual impairment due to macular edema secondary to BRVO.

The trial’s 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.

The company noted that more than half of the patients who were treated with aflibercept solution for injection gained at least three lines of vision.

The recommended treatment approach is to start therapy with one injection per month until maximum visual acuity is achieved.

Bayer HealthCare Executive Committee member and Global Development head Dr Joerg Moeller said: "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.

"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."

Currently, Eylea has been approved in more than 80 countries to treat neovascular age-related macular degeneration (wet AMD) and around 40 countries for visual impairment due to macular edema secondary to central retinal vein occlusion.

Eylea, which is being jointly developed by Bayer and Regeneron, is also approved for the treatment of diabetic macular edema (DME) in over 40 countries.

Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.