Bayer Files For New Eylea Indication In Japan

Bayer announced that its unit Bayer Yakuhin has filed a new Marketing Authorization application in Japan for aflibercept solution for injection into the eye as treatment for branch retinal vein occlusion (BRVO).

Aflibercept solution for injection into the eye (brand name Eylea) is a recombinant fusion protein. It has already received approval in Japan for the treatment of macular edema secondary to central retinal vein occlusion (CRVO) and neovascular age-related macular degeneration (wet AMD). Earlier this year the company received a new approval in the EU for Eylea as treatment for diabetic macular edema.

The submission of the new MAA is based on the results of the Phase III VIRANT trial investigating Eylea in patients with macular edema secondary to branch retinal vein occlusion. BRVO is a common retinal vascular disorder affecting an estimated 14 million people in the world. A major cause of visual impairment, BRVO stems from the blockage of one or more branches of the main blood vessels draining the retina. This results in vascular endothelial growth factor and accompanying retinal edema.

Dr. Erik Louvel, head of product development of Bayer Yakuhin, shared that the submission is the fifth for Eylea in Japan. “In Japan, approximately 2.0 percent 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.”

In the study, 53 percent of Japanese patients regained at least 15 letters, or three lines, in best corrected visual acuity from baseline at week 24 compared to only 27 percent of patients who received laser treatment. In addition to meeting the trial’s primary endpoint, Eylea also achieved a key secondary endpoint in the trial consisting of letter mean improvement over baseline compared to laser treatment.

Bayer is developing aflibercept solution for injection into the eye in collaboration with Regeneron Pharmaceuticals.