Positive outcome to EU decentralized approval of Iluvien (Almeria Sciences) for DME

There has been a positive outcome of the Decentralized Procedure (DCP) for Iluvien (fluocinolone acetonide), from Alimera Sciences, in Europe for treatment of Diabetic Macular Oedema (DME). The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that Iluvien is approvable. The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. Iluvien will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. The announcement is based on clinical trial data showing that in patients with chronic DME at month 30, after receiving the Iluvien implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. Alimera Sciences is also meeting the FDA to discuss its requirements for a third resubmission of Iluvien, following the failure of an NDA for not providing sufficient data to support the drug's safety and efficacy.