European Commission approves Eylea to treat diabetic macular edema

The company, which is collaborating with Regeneron Pharmaceuticals on the global development of Eylea, intends for an immediate roll-out with Germany being one of the first launch countries in Europe.

Bayer HealthCare member of the executive committee and head of Global Development Joerg Moeller said the approval of Eylea in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DME.

"This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions," Moeller said.

CHU Bordeaux chief of Ophthalmology and principal investigator of the VIVID-DME trial Jean-Francois Korobelnik said the results of two Phase III studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection.

"Early diagnosis of DME is critical, and if not treated rigorously, there is a high risk of DME leading to blindness," Korobelnik said.

Eylea has been approved in many countries to treat neovascular age-related macular degeneration (wet AMD) as well as for visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

The company said that regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME.