Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer HealthCare has received the approval of the Australian Therapeutic Goods Administration (TGA) for its Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).
Subscribe to our email newsletter
FDA-approved Eylea injection is a recombinant fusion protein, consisting of portions of human Vascular Endothelial Growth Factor (VEGF) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.
The approval is backed by the results from the two positive Phase 3 clinical studies, VIEW 1 and VIEW 2.
Eylea is currently in a Phase 3 clinical study for the treatment of wet AMD in China, diabetic macular edema (DME), myopic choroidal neovascularisation (mCNV), and branch retinal vein occlusion (BRVO).
The drug has been cleared for use at a recommended dose of 2mg via intravitreal injection per month for three consecutive months, followed by 2mg via intravitreal injection every two months.
Eylea-related common adverse reactions included conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters, and increased intraocular pressure.