Ozurdex dexamethasone intravitreal implant regulatory update

Allergan said FDA approved an sNDA to expand the label of Ozurdex dexamethasone intravitreal implant to include treatment of diabetic macular edema (DME) in adults who have an artificial lens implant or who are scheduled for cataract surgery. The biodegradable implant is approved in the U.S. and EU to treat macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and in the U.S. to treat non-infectious uveitis affecting the posterior segment of the eye. Ozurdex is also under review in the EU to treat DME. ...