Regeneron Pharmaceuticals and Bayer HealthCare have commenced a new Phase III trial of their Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME) in Russia, China, and other Asian countries.
Formulated as an iso-osmotic solution for intravitreal administration, recombinant fusion protein Eylea acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), and inhibits the binding and activation of these cognate VEGF receptors.
The trial, named VEGF Trap-Eye In Vision Impairment Due to DME (VIVID EAST-DME), includes three treatment arms.
2mg of Eylea will be given to the first arm of patients every month and to the second arm of patients every two months, after an initial phase of five monthly injections.
The third comparator arm patients will be treated with macular laser photocoagulation, the currently available treatment for DME, according to the company.
Mean change in visual acuity from baseline to week 52, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, is the primary endpoint for the trial.
The study is expected to follow patients for a maximum of one year.
Previously, Eylea was approved for the treatment of wet age-related macular degeneration (AMD) in the US, Japan, Europe, Australia, and several other countries.
A separate Phase III trial of Eylea in DME, named VIVID-DME, will be conducted by Bayer HealthCare in Europe and Japan and a second study, named VISTA-DME will be conducted by Regeneron in the US.
In addition, Phase III trials are currently underway with Eylea in the treatment of myopic choroidal neovascularisation (mCNV) in Asia, and macular edema following branch retinal vein occlusion (BRVO) in the US, Canada and Japan.