Bayer Announces Japanese Market Authorization Of Eylea 8mg

(RTTNews) - Bayer AG (BYR.L) on Thursday announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the market authorization of Eylea 8 mg (aflibercept 8 mg) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Eylea 8 mg is a drug jointly developed by Bayer and Regeneron, known as Eylea HD in the United States. Regeneron has exclusive rights to Eylea 2 mg and Eylea HD in the United States while Bayer holds exclusive marketing rights outside the United States.

The approval was granted based on the positive results obtained from two clinical trials: the PULSAR clinical trial in nAMD and the PHOTON clinical trial in DME. The PULSAR clinical trial evaluated the efficacy and safety of Eylea 8 mg in comparison to Eylea 2 mg in patients with nAMD while the PHOTON clinical trial assessed the safety and efficacy of Eylea 8 mg in patients with DME.