Alimera Sciences Announces Positive Outcome Of Repeat-Use Procedure For Iluvien

(RTTNews) - Alimera Sciences Inc. (ALIM) announced the positive outcome of the Repeat-Use Procedure for Iluvien for the treatment of chronic diabetic macular edema or DME in an additional 10 European Union countries.

Alimera said it submitted the application through the Mutual Recognition Procedure or MRP with the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) serving as the Reference Member State.

The company noted that 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 will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.

Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc).

Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. Iluvien has not been approved for sale in the United States, the company said.