Bayer HealthCare has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the approval of VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME).
Regeneron Pharmaceuticals has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for VEGF Trap-Eye in this indication.
In Europe, the US, Japan, Australia and in many other countries, VEGF Trap-Eye has been approved under the brand name Eylea for the treatment of patients with neovascular age-related macular degeneration (wet AMD).
The company said that Eylea has also been approved in Europe for treating visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), as well as in the US and in selected Asian and Latin American countries for the treatment of macular edema following CRVO.
Bayer HealthCare member of the executive committee Kemal Malik said the number of patients suffering from diabetes on a worldwide basis continues to increase.
"With this filing, Bayer and Regeneron hope to make a significant contribution towards alleviating the impact of this disease in the future," Malik said.
The MAA is based on data from the positive results secured from Phase III VISTA-DME and VIVID-DME studies, which are planned to continue up to 148 weeks.
According to Bayer, 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.
By acting as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), VEGF Trap-Eye can inhibit the binding and activation of their cognate VEGF receptors.
The drug candidate is currently in Phase III trials for treatment of diabetic macular edema, choroidal neovascularisation, age related macular degeneration, myopia, central retinal vein occlusion, and neovascular form of wet AMD.
Both firms are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights to Eylea in the US and Bayer having exclusive marketing rights outside the US, where the companies share the profits equally from its sales, except for Japan where Regeneron receives a royalty on net sales.
Image: Diabetic macular edema. Photo: courtesy of GeeJo.