Alimera Sciences, Inc., announced the National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) has granted marketing authorization to Iluvien 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 (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for Iluvien along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The Portuguese authorization is the third national approval in the EU, preceded by Austria and the U.K.
"Today's authorization in Portugal is significant news for the many people there with chronic DME who haven't responded well to available therapies," said Dan Myers, president and chief executive officer, Alimera Sciences. "Having now received three EU national approvals, we are gaining momentum across the continent and are on track to obtain subsequent approvals from additional CMS in the coming months."
The International Diabetes Federation estimates that more than 1,000,000 people are currently living with diabetes in Portugal, and according to Alimera's estimates, more than 55,000 people suffer from vision loss associated with DME.
Iluvien is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The clinical trial data showed 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. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.
"As an avid proponent of retinal disease research and novel therapeutics, I am pleased to see this treatment option enter the
Portuguese marketplace," said Jose Cunha-Vaz, M.D., Ph.D., emeritus professor of Ophthalmology, University of Coimbra and chairman of the Diabetic Retinopathy and Retinal Vascular Diseases Expert Committee, European Vision Institute Clinical Research Network. "Iluvien could have a considerable effect on the way chronic diabetic macular edema patients are treated in this country and the European Union at large."