Bayer HealthCare has filed an application to the European Medicines Agency (EMA) seeking marketing approval for aflibercept solution for injection to treat patients with macular edema following branch retinal vein occlusion.
The company has submitted the aflibercept solution for injection for the EU marketing authorisation based on data from the VIBRANT study.
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 branch retinal vein occlusion.
In the VIBRANT study, 53% of patients who received aflibercept solution for injection 2mg monthly gained at least 15 letters (equivalent to three lines) in best corrected visual acuity (BCVA) from baseline at week 24, the primary endpoint of the study, compared with 27% of patients who received laser.
The study met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in best corrected visual acuity compared with a 6.9 letter mean improvement in patients who received laser.
Aflibercept solution for injection into the eye was generally well-tolerated in the VIBRANT study.
Previously, aflibercept solution for injection into the eye was approved under the brand name EYLEA for treatment of patients with neovascular age-related macular degeneration and treatment of visual impairment due to macular edema secondary to central retinal vein occlusion.
Bayer HealthCare has already applied for marketing approval of aflibercept solution for injection for the treatment of diabetic macular edema.
Bayer HealthCare executive committee member and global development head Dr Joerg Moeller said: “The submission is an important milestone as it marks the fourth regulatory submission in the EU for aflibercept solution for injection into the eye in the past few years.”
Image: Branch retinal vein occlusion is a common retinal vascular disease of the elderly. Photo: courtesy of Kiatdd.