The US Food and Drug Administration (FDA) has approved a low-dose corticosteroid intravitreal implant for the treatment of diabetic macular oedema. (DME).
The US Food and Drug Administration (FDA) has approved Alimera Sciences' ILUVIEN low-dose corticosteroid intravitreal implant for the treatment of diabetic macular oedema. (DME).
ILUVIEN is already approved for marketing in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and Sweden, and is commercially available in the UK and Germany.
"This is a major milestone for Alimera Sciences, delivering further momentum to our geographic expansion, but more importantly providing a long-term treatment option for American patients with DME," said Philip Ashman, PhD, senior vice president and European managing director, Alimera Sciences. "The news from the FDA only adds to our confidence that ILUVIEN will become an important global brand in ophthalmology."
ILUVIEN (190 micrograms intravitreal implant in applicator) provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc).
Alimera Sciences expects to begin selling ILUVIEN in the US market during the first quarter of 2015.