TARRYTOWN, N.Y. and BERLIN, March 8, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare today announced that Bayer HealthCare has received approval from the Australian Therapeutic Goods Administration (TGA) for EYLEA® (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg) via intravitreal injection per month for three consecutive months, followed by 2 milligrams via intravitreal injection every two months. Bayer Healthcare plans to launch EYLEA in Australia in the second half 2012.
"The approval of EYLEA represents an important new option for wet AMD patients in Australia," said George D Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "EYLEA allows for clinical efficacy that is non-inferior to monthly ranibizumab, but with fewer injections and less frequent office visits. We believe that this may help reduce treatment challenges for wet AMD patients and their physicians in Australia."
The TGA approval of EYLEA is based upon the results of two positive Phase 3 clinical studies (VIEW 1 and VIEW 2) which demonstrated that EYLEA dosed every other month, following 3 initial monthly injections, was non-inferior to Lucentis® (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in patients receiving EYLEA were conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters, and increased intraocular pressure.
EYLEA is currently in a Phase 3 clinical study for wet AMD in China. Beyond the wet AMD indication, EYLEA is in Phase 3 clinical studies for the treatment of diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), branch retinal vein occlusion (BRVO). Bayer HealthCare has submitted applications for marketing authorization in Europe, Japan, and other countries for EYLEA for the treatment of wet AMD in 2011. Regeneron has filed an sBLA for EYLEA in central retinal vein occlusion (CRVO) in the United States, and has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23, 2012.Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA®. EYLEA was approved in the United States for the treatment of wet AMD in November 2011. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare owns the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA. About EYLEA® (aflibercept) Injection For Intravitreal InjectionVascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results. EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human 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. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.