Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., received approval for Eylea (aflibercept) injection from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO), it was announced by Regeneron Pharmaceuticals, Inc.
This new indication includes macular edema secondary to branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion (CRVO).
The approval is based on positive results from the double-masked, randomized, active-controlled phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO. The primary endpoint was the proportion of subjects who gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. More than half of the patients who were treated with aflibercept solution for injection gained at least three lines of vision.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
RVO is a significant cause of vision impairment and a chronic disease that requires early and ongoing management to obtain the best possible vision.
Retinal vein occlusion (RVO) includes branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). RVO is a chronic eye condition that can lead to sudden vision loss and is second only to diabetic retinopathy as the most frequent cause of visual loss from diseases affecting the blood vessels of the retina. While each patient experiences RVO differently, all patients are at risk for vision loss which can impact their ability to participate in everyday activities and may cause significant financial burden to patients, their families as well as broader society. RVO has a significant global impact with an estimated 16.4 million people affected worldwide, including around 13.9 million with BRVO and 2.5 million with CRVO.
RVO is the result of a blockage in a blood vessel of the retina, the light sensitive part of the eye. In CRVO, the blockage occurs in the main retinal vein at the optic nerve. In BRVO, the blockage occurs in one of the branch retinal veins. If a blockage in any of the retinal veins (central or branch) is not resolved, it can result in a number of complications. The most common reason for vision impairment in patients with RVO is macular edema, swelling of the macula, which is the central portion of the retina responsible for seeing fine details.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. Eylea helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.