Bayer’s Eylea Receives Fifth Indication in Japan for Neovascular Glaucoma

Compiled by newborn

Bayer Yakuhin, a Japanese subsidiary of Bayer, and Santen Pharmaceutical recently announced the joint approval of Eylea (aflibercept) in Japan for a new indication: the treatment of neovascular glaucoma (NVG). This approval covers both the Eylea vial and the Eylea pre-filled syringe. Eylea is the first drug globally approved for the treatment of NVG and had previously been granted orphan drug designation for this indication.

NVG is also the fifth indication approved for Eylea in Japan; the other four indications are: neovascular (wet) age-related macular degeneration with subfoveal choroidal neovascularization, macular edema secondary to retinal vein occlusion, choroidal neovascularization due to pathologic myopia, and diabetic macular edema.

This approval is based on data from two Phase III studies: the randomized, double-blind, controlled VEGA study and the open-label, single-arm VENERA study. These studies investigated the efficacy, safety, and tolerability of intravitreal Eylea injections in Japanese patients with neovascular glaucoma (NVG). Pooled results demonstrated that both studies confirmed the efficacy of Eylea, meeting the primary endpoint of a significant reduction in intraocular pressure (IOP) relative to baseline at Week 1, as well as the secondary endpoint of a significant improvement in the neovascularization of the iris (NVI) score relative to baseline at Week 1. The adverse events observed in both studies were consistent with the known safety profile of Eylea.

Neovascular glaucoma (NVG) is a secondary glaucoma characterized by the formation of new blood vessels on the iris and in the anterior chamber angle. Aqueous humor outflow is impaired, leading to elevated intraocular pressure. NVG is a severe complication primarily associated with retinal ischemic conditions such as proliferative diabetic retinopathy and central retinal vein occlusion. Due to the risk of blindness from disease progression, there remains a significant unmet medical need for effective treatments.

Dr. Masaru Inatani, Professor of Ophthalmology at the University of Fukui Faculty of Medical Sciences, stated, “NVG is a refractory glaucoma that can easily lead to blindness, thus requiring urgent treatment. Previously, there were no approved therapies directly targeting VEGF to induce regression of neovascularization and lower intraocular pressure. With Eylea receiving the world’s first approval in Japan for the treatment of NVG, it will provide a new treatment option for patients in Japan.”

Eylea is a novel intravitreal VEGF inhibitor. Its active pharmaceutical ingredient, aflibercept, is a recombinant fusion protein composed of the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of human immunoglobulin G1. Eylea functions as a soluble decoy receptor for members of the VEGF family (including VEGF-A) and placental growth factor (PlGF). It binds these factors with high affinity, thereby inhibiting their binding to and activation of cognate VEGF receptors, which in turn suppresses abnormal angiogenesis and vascular leakage.

Eylea was globally developed through a collaboration between Bayer and Regeneron for the treatment of various retinal diseases. Regeneron retains exclusive rights in the United States, while Bayer holds exclusive commercialization rights in countries and regions outside the United States.

Reference Source: Intravitreal VEGF Inhibitor EYLEA Approved as a Treatment for Neovascular Glaucoma (NVG), Its Fifth Indication

Responsible Editor: Mengmeng

Disclaimer: This article is reposted from Yaozhi.com. The copyright belongs to the original author. The purpose of reposting is to convey more information, which does not represent the views of this platform. If there are any issues regarding the content, copyright, or other matters, please leave a message on our website, and we will remove the content promptly!