Bayer has announced the US Food and Drug Administration’s (FDA) approval of Eylea, an aflibercept solution for injection into the eye for the treatment of diabetic macular edema (DME).
The company said that DME is the third approved application for Eylea. The FDA approval is supported by a positive outcome from the Phase III VISTA-DME and VIVID-DME clinical trials, which included 862 patients.
The studies compared aflibercept solution given through monthly 2mg injections, 2mg given every two months after five initial monthly injections or macular laser photocoagulation as a baseline treatment and then as needed.
After one year, the mean changes in best-corrected visual acuity were significantly improved compared with the control group and were similar to each other in clinical trials.
According to Bayer, aflibercept solution for injection was generally well tolerated with similar overall incidence of adverse events (AEs), ocular serious AEs and non-ocular serious AEs across treatment groups and the control group in the clinical trials.
“After one year, the mean changes in best-corrected visual acuity [of patients treated with Eylea] were significantly improved compared to the control group.”
Eylea consists of portions of human vascular endothelial growth factor 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 was approved in many countries for treatment of patients with neovascular age-related macular degeneration and for visual impairment due to macular edema secondary to central retinal vein occlusion.
Bayer HealthCare and Regeneron Pharmaceuticals are collaborating on the global development of Eylea. In the US, Regeneron holds exclusive marketing rights to Eylea, while Bayer HealthCare has exclusive rights outside the US.