JUL 02, 2014
Comprehensive Ophthalmology, Retina/Vitreous
Alimera Sciences, Inc., has obtained a positive outcome of the Repeat-Use Procedure for Iluvien for chronic diabetic macular edema (DME), moving the intravitreal implant closer to marketing approval in an additional 10 European Union countries.
The regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland and the Czech Republic, will now enter the national phase in which each country grants marketing authorization.
Iluvien is a sustained release, fluocinolone acetonide implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies, providing a therapeutic effect of up to 36 months.
After a medicine is first authorized in one EU member state, a company can use the same authorization more than once after completion of the first decentralized procedure, which is known as Repeat-Use.
The initial Iluvien decentralized procedure resulted in marketing authorizations in Austria, Portugal, the United Kingdom, Germany, France, Spain and Italy. Iluvien is currently commercially available in the United Kingdom and Germany.