Regeneron Pharmaceuticals and Bayer HealthCare have started a new Phase 3 VEGF Trap-Eye In Vision Impairment Due to DME (VIVID EAST-DME) trial of its Eylea (aflibercept) injection.
Eylea, which is formulated as an iso-osmotic solution for intravitreal administration, is designed for the treatment of diabetic macular edema (DME) in Russia, China, and other Asian countries.
The trial will be comprised of three treatment arms with the first arm to receive Eylea of 2 milligrams (mg) for every month, while the second arm to receive 2mg Eylea every two months, after an initial phase of five monthly injections, according to the company.
The third comparator arm patients will be treated with macular laser photocoagulation, the currently available treatment, for DME.
The primary endpoint of the trial includes mean change in visual acuity from baseline to week 52, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
The company is expecting to follow DME 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.
Separate Phase 3 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.