Date: 2011-11-28
Type of information: Initiation of preclinical development
phase: 3
Announcement:
Company: Bayer HealthCare (Germany) Regeneron Pharmaceuticals (USA)
Product: Eylea® (aflibercept)
Action
mechanism: fusion protein/VEGF receptor. Eylea® 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.
Disease: neovascular form of age-related macular degeneration (wet AMD)
Therapeutic area: Ophtalmological diseases
Country: China
Trial
details: The SIGHT (VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese patients with wet AMD) program consists of a randomized, double-masked, Phase 3 clinical trial evaluating Eylea® (known in the scientific literature as VEGF Trap-Eye) in the treatment of the neovascular form of age-related macular degeneration (wet AMD). Eylea® will be evaluated for its effect on improving and maintaining vision when dosed as an intravitreal injection on a schedule of 2 milligrams (mg) every two months (following three initial monthly doses), as compared with Photodynamic Therapy (PDT) with verteporfin. After assessment of the primary endpoint at week 28, all patients, including those on PDT, will receive Eylea® treatment until the end of the study at week 52. The SIGHT study plans to randomize 300 patients.
Latest
news: Regeneron Pharmaceuticals and Bayer HealthCare have initiated a Phase 3 clinical trial evaluating the efficacy and safety of Eylea®(aflibercept) Injection in the neovascular form of age-related macular degeneration (wet AMD) in China. The new trial, named SIGHT, will include approximately 300 patients and will be the largest retinal trial conducted in China. SIGHT is being led by Bayer.
