The MAA is based on the positive results from the data collected in Japan as part of the Phase III VIBRANT trial.
The trial, which met its primary endpoint, showed that 53% of patients who received aflibercept solution for injection 2mg monthly gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24.
Data from week 24 was compared to 27% of patients who received laser, the current standard of care.
Additionally, aflibercept solution met a key secondary endpoint, by achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser treatment.
In Japan, aflibercept solution for injection is already approved under the brand name Eylea to treat patients with neovascular age-related macular degeneration (wet AMD) as well as for the treatment of macular edema secondary to central retinal vein occlusion (CRVO).
The company has also submitted marketing authorization applications in Japan to treat choroidal neovascularization secondary to pathologic myopia (myopic CNV) and diabetic macular edema (DME).
Bayer Yakuhin Product Development head Dr Erik Louvel said BRVO is a common retinal vascular disorder with an estimated 14 million people affected worldwide.
"In Japan, approximately 2.0% of residents over the age of 40 are estimated to have BRVO. It is a severe disease which may lead to permanent vision loss if the macular edema is not treated appropriately," Louvel said.
"This submission which is the fifth application for aflibercept solution for injection in Japan reinforces the commitment of Bayer to improving outcomes for the millions of patients suffering from a broad range of vision-threatening retinal diseases."
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.