Alimera Sciences has filed Illuvien, its treatment for diabetic macular oedema with regulators in Europe, a weelk after making a submission to the US Food and Drug Administration.

The US biopharmaceutical company has submitted a marketing authorisation application to the Medicines and Healthcare products Regulatory Agency in the UK) for Iluvien (fluocinolone acetonide). The drug is released into the eye using sustained drug delivery system.

The MAA is being submitted through the decentralised procedure, while applications have also been submitted to other 'concerned member states' in the European Union - Austria, France, Germany, Italy, Portugal and Spain. The filing comes on the back of a New Drug Application to the FDA and a submission in Canada is imminent.

The MAA is based on data from two ongoing Phase III clinical trials (collectively known as the FAME Study) involving 956 patients. The primary efficacy endpoint is the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the standard ETDRS eye chart at month 24. The study will conclude later this year with the final patient visits at the three-year data point.

Chief executive Dan Myers said that Iluvien, if approved, “will be welcomed by physicians and patients alike as a much-needed, long-term alternative to the multiple injections of corticosteroids and anti- vascular endothelial growth factor therapies currently used off-label for DMO”. Following the FDA filing, he said “we believe this would be the first ophthalmic drug therapy to be approved for DMO and the only DMO treatment that works in terms of years, not months”.