Aflibercept 8 mg filed for marketing authorization in Japan
-Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
The MHLW submission is based on positive results from both the phase III PULSAR trial in nAMD and the phase II/III PHOTON trial in DME, in which aflibercept 8 mg met its primary endpoint, respectively. Aflibercept 8 mg has been developed with the aim to increase intervals between injections without compromising vision gains.
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