Aflibercept submitted for fourth indication in EU

June 19, 2014

Bayer HealthCare has applied to the EMA for marketing authorization of aflibercept solution for injection for the treatment of patients with visual impairment caused by macular oedema secondary to BRVO.

Bayer HealthCare has applied to the European Medicines Agency (EMA) for marketing authorization of aflibercept solution for injection (EYLEA) for the treatment of patients with visual impairment caused by macular oedema secondary to branch retinal vein occlusion (BRVO).

Aflibercept solution for injection into the eye is approved for the treatment of patients with neovascular age-related macular degeneration and the treatment of visual impairment caused by macular oedema secondary to central retinal vein occlusion. Bayer has previously filed for marketing authorization for the treatment of diabetic macular oedema (DME).

The EMA submission is based on the positive results from the Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular oedema secondary to BRVO. In the VIBRANT study, 53% of patients who received aflibercept solution for injection 2 mg monthly gained at least 15 letters (equivalent to three lines) in best corrected visual acuity (BCVA) from baseline at week 24, compared to 27% of patients who received laser. In addition, the patients who received aflibercept solution for injection achieved a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser.

Aflibercept solution for injection into the eye has been approved in more than 70 countries for the treatment of patients with neovascular age-related macular degeneration and nearly 60 countries for the treatment of visual impairment caused by macular oedema secondary to central retinal vein occlusion (CRVO).

Regulatory submissions have been made in Europe, Japan, Asia Pacific, Latin America and the US for the treatment of diabetic macular oedema (DME), and for BRVO in the US. Approval is being sought in Japan and Asia Pacific, for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV).

For more details visit the company's website.