Bayer and partner Regeneron Pharmaceuticals have initiated the first of two Phase III clinical trials evaluating VEGF Trap-Eye for the treatment of diabetic macular oedema.
The move into late-stage trials folows promising results in Phase II. The first Phase III study, VIVID-DME, is being led by Bayer and has already started in Australia. It will also be conducted in Europe and Japan. A second study of VEGF Trap-Eye (aflibercept), led by Regeneron, named VISTA-DME, is expected to begin later in 2011 in the USA, Canada, and other countries.
Kemal Malik, head of global development at Bayer HealthCare, noted that "clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes". News of this latest study programme comes after the partners recently reporting positive results from two Phase III studies of VEGF Trap-Eye in age-related macular degeneration and from the first of two late-stage trials in patients with central retinal vein occlusion.