Alimera's Iluvien approved in France for diabetic macular edema

USA-based ophthalmic biopharma specialist Alimera Sciences (Nasdaq: ALIM) says that French regulator the National Security Agency of Medicines and Health Products has granted marketing authorization to Iluvien (fluocinolone acetonide intravitreal insert) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

This marketing authorization follows the completion of the decentralized regulatory procedure (DCP) in the European Union, in which the UK’s Medicines and Healthcare products Regulatory Agency, serving as the reference member state, delivered a positive outcome for Iluvien along with six concerned members states, specifically Austria, France, Germany, Italy, Portugal and Spain. The French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK (The Pharma Letter June 6).

The International Diabetes Federation estimates that more than 4,300,000 people are currently living with diabetes in France, and according to Alimera's estimates, more than 220,500 people suffer from vision loss associated with DME.