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FDA News Briefs for Wednesday, May 15, 2019

May 15, 2019

These Food and Drug Administration (FDA) developments came in this week:


FDA Expands Approval for Eylea

The FDA has approved a supplemental biologics license application for Eylea (aflibercept; Regeneron). Eylea is a vascular endothelial growth factor (VEGF) inhibitor now indicated for the treatment of diabetic retinopathy. It is administered via intravitreal injection. Eylea was previously FDA-approved for wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. More Information.  


FDA Expands Approval for Xeomin

The FDA has granted expanded approval for Xeomin (incobotulinumtoxinA; Merz Pharmaceuticals LLC), an acetylcholine release inhibitor and neuromuscular blocking agent. Xeomin is now indicated for the treatment of blepharospasm in adult patients. The initial recommended dose for patients with treatment-naïve blepharospasm is 25 units per eye. Xeomin was previously FDA-approved for chronic sialorrhea (drooling), upper limb spasticity, cervical dystonia, and temporary improvement in glabellar lines. More Information.