Bayer HealthCare announced that Bayer Yakuhin Ltd., Osaka, Japan, has submitted an application for marketing authorization for aflibercept solution for injection into the eye, based on the Phase 3 VIBRANT trial in patients with macular edema secondary to branch retinal vein occlusion (BRVO). Aflibercept solution for injection into the eye has already been approved in Japan under the brand name Eylea for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and the treatment of macular edema secondary to central retinal vein occlusion (CRVO).Marketing authorization applications have also been submitted in Japan for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV) and for the treatment of diabetic macular edema (DME).
“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,” said Dr. Erik Louvel, head of product development of Bayer Yakuhin. “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.”
The submission is based on the positive results from the data collected in Japan as part of the Phase 3 VIBRANT trial. In the VIBRANT study, 53% of patients who received aflibercept solution for injection 2 milligram (mg) 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 to 27% of patients who received laser, the current standard of care (p<0.001). In addition, aflibercept solution for injection met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser (p<0.0001).
Aflibercept solution for injection into the eye was generally well tolerated. Through week 24, the most common ocular adverse events in patients treated with aflibercept solution for injection were conjunctival hemorrhage and eye pain. The incidence of serious adverse events (SAE) was 9.9% in the aflibercept solution for injection group and 9.8% in the laser group. Up to week 24, one death and one Anti-Platelet Trialists’ Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both events occurred in patients in the laser group. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the aflibercept solution for injection group, which was a traumatic cataract.
Date: September 4, 2014
Source: Bayer HealthCare
