Insight on Bayer’s EU approval of new treatment regimen for Eylea

Bayer has received European Commission approval of a new treatment approach for Eylea to enable clinicians to combine proactive treatment with early extension of the injection interval for patients with neovascular age-related macular degeneration (nAMD). The new regimen allows clinicians already in the first year of treatment to extend patients’ individual injection intervals based on visual and/ or anatomic outcomes.

The new approach is based on results from the ALTAIR study, in which after 52 weeks 57% of patients had their next regularly scheduled Eylea injection at an interval of 12 weeks or more. Treatment intervals up to 16 weeks between injections have been studied. Patients participating in the study gained an average of up to 9.0 letters, including 50% of participants who gained 10 or more letters of vision at week 52, as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart. These results were largely maintained during the second year, demonstrating the sustainability of this proactive approach.

Eylea has been approved in the majority of countries for five indications to treat patients with: neovascular AMD (wet AMD), visual impairment due to diabetic macular edema (DME), retinal vein occlusion (RVO; branch RVO or central RVO) and myopic choroidal neovascularization. Eylea is the global market leader of anti-VEGF treatment, with estimated around 20 million doses administered worldwide since launch.

Bayer and Regeneron Pharmaceuticals Inc. are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.