European Commission approves Eylea for early extension of the injection interval for patients with neovascular age-related macular degeneration.-Bayer + REgeneron.

Bayer announced that the European Commission has approved 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.

The updated product information brings forward a proactive ‘Treat and Extend’ (T&E) dosing regimen. This offers physicians the option already in the first year of Eylea treatment to extend their patients’ injection intervals by two- or four-weekly increments following initial dosing. If visual and/or anatomic outcomes deteriorate during the T&E dosing regimen, the treatment interval should be shortened accordingly. The initial doses are three consecutive monthly doses, followed by one injection after two months.