MHLW approves Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema

The approval is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON clinical trial in DME. In these clinical trials, aflibercept 8 mg demonstrated unprecedented durability for the vast majority of patients with less frequent injections and comparable efficacy and safety to Eylea 2 mg (aflibercept 2 mg) with a fixed 8-week treatment interval.

“The approval of Eylea 8 mg in Japan is a turning point in retinal care. Eylea 2 mg already transformed the treatment landscape a decade ago and is the standard of care in nAMD and DME today. Building on this high therapeutic standard, patients now have the option to benefit from Eylea 8 mg with less frequent injections and still experience lasting vision gains, rapid and resilient fluid control, and comparable safety to Eylea 2 mg,” said Michael Devoy, Chief Medical Officer at Bayer’s Pharmaceuticals Division.