- Alimera Sciences has received approval from the Norway Medicines Evaluation Board for the use of Iluvien to treat diabetic macular edema (DME) that is not responsive to first-line therapies.
- Iluvien is also approved in Austria, France, Germany, Italy, Portugal, Spain and the UK.
- Although Iluvien is not yet approved by the FDA, the product is currently under review.
Iluvien is an injectable intravitreal implant that is designed to release fluocinolone acetonide. The global prevalence of DME is estimated to be 21 million, with one million people affected by DME in the US alone.
Alimera has been building a strong presence across Europe. In addition to the countries in Europe where Iluvien is already approved, approval is pending in Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden. The company also plans on expanding Iluvien's marketing in Portugal, where the drug has received reimbursement approval.