Alimera Sciences Inc, a United States biopharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals has submitted a Marketing Authorisation Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien (fluocinolone acetonide intravitreal insert).
Iluvien is Alimera’s investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).
The MAA is being submitted through the Decentralised Procedure with the UK MHRA as the Reference Member State (RMS). Applications have also been submitted to the following other Concerned Member States (CMS) in the European Union: Austria, France, Germany, Italy, Portugal and Spain.
“This MAA submission closely follows the submission of our NDA to the US Food and Drug Administration last week, and marks an important first step toward the availability of a sustained release treatment for DME patients in Europe,” said Dan Myers, president and CEO of Alimera.
“We anticipate 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-VEGF therapies currently used off-label for DME.”
Alimera is currently conducting two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across Canada, Europe, India and the United States to assess the efficacy and safety of Iluvien with two doses, a high and low dose, for the treatment of DME.
The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups.
The study will conclude later this year with the final patient visits at the three-year data point.
This MAA submission includes the 24-month low dose data from the FAME Study. In December 2009, the 24-month clinical readout from the FAME Study was completed and announced. Alimera plans to follow this MAA submission with a registration filing in Canada in the near future.