- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Will Review Eylea (Aflibercept) for Treatment of Macular Edema Following Retinal Vein Occlusion
Approval decision expected in October (February 24)
The FDA has accepted for standard review the supplemental biologics license application (sBLA) for Eylea (aflibercept, Regeneron) injection for the treatment of macular edema following branch retinal vein occlusion (BRVO). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is 10 months from submission, for a target action date of October 23, 2014.
Eylea (aflibercept) was approved in the U.S. for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012.
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body. Its normal role is to trigger the angiogenesis that supports the growth of the body’s tissues and organs. However, in certain diseases, such as wet AMD, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability leading to edema. Scarring and loss of fine-resolution central vision often results.
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human immunoglobulin G1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), thereby inhibiting the binding and activation of their cognate VEGF receptors.
Source: Regeneron Pharmaceuticals; February 24, 2014.