Bayer Yakuhin has tendered a new application in Japan for marketing authorisation for its aflibercept solution for injection in the eye.
The company submitted the application based on positive results from the Phase III Vibrant trial in patients with macular edema secondary to branch retinal vein occlusion (BRVO).
Bayer Yakuhin product development head 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.
“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.”
“This submission reinforces the commitment of Bayer to improving outcomes for the millions of patients suffering from a broad range of vision-threatening retinal diseases.”
Bayer noted Vibrant study reached the primary endpoint, with 53% of patients receiving aflibercept solution for injection 2mg monthly and gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24, compared with 27% of patients who received laser, the current standard of care (p<0.001).
With around 60 study sites in Japan and North America, Vibrant was a Phase III, randomised, double-masked, active-controlled 52-week study, comparing aflibercept solution for injection 2mg monthly with laser photocoagulation in subjects with macular edema secondary to BRVO.
In Japan, Aflibercept solution for injection has already received approval under the brand name EYLEA to treat patients with neovascular age-related macular degeneration (wet AMD) and macular edema secondary to central retinal vein occlusion (CRVO).
In addition, the company has submitted marketing authorisation applications in the country to treat choroidal neovascularisation secondary to pathologic myopia (myopic CNV) and diabetic macular edema (DME).
Image: Colour fundus photograph of the left eye shows occlusion of the superotemporal branch of retinal vein. Photo: courtesy of Ku C Yong, Tan A Kah, Yeap T Ghee, Lim C Siang and Mae-Lynn C Bastion, Department of Ophthalmology, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and Universiti Malaysia Sarawak (UNIMAS), Kuala Lumpur, Malaysia.