Bayer submits aflibercept 8 mg for marketing authorization in Japan

01

March

2023

Summary

Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PULSAR and PHOTON / In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as well as rapid and resilient fluid control to the comparator Eylea^TM (aflibercept 2 mg) through to week 48 / Safety of aflibercept 8 mg was consistent with the safety profile of Eylea (aflibercept 2 mg) / Extended treatment intervals with fewer injections addresses an important patient need