Austrian Agency for Health and Food Safety (Osterreichische Agentur fur Gesundheit und Ernahrungssicherheit, AGES) has granted marketing authorization to Alimera Sciences Inc.s' 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 which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State, delivered a positive outcome for Iluvien along with six Concerned Members States (CMS), which include Austria, France, Germany, Italy, Spain and Portugal. The Austrian authorization is the first national approval in the EU. Additional CMS marketing authorizations are expected in the coming months.
Iluvien (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat chronic DME. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.
“We are excited to receive this marketing authorization and pleased that DME patients in Austria will have this therapy available to them. We look forward to receiving the additional expected approvals from the U.K. and other Concerned Member States as we continue on track with our commercialization plans in the EU,” said Dan Myers, president and chief executive officer, Alimera Sciences.
The International Diabetes Federation estimates that approximately 750,000 people are currently living with diabetes in Austria, and according to Alimera's estimates, more than 40,000 people suffer from 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 per cent 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 per cent 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.
“With the approval of Iluvien, Austrians who are suffering from chronic diabetic macular edema and unresponsive to current therapies can now be offered another chance to maintain their vision,” said Dr Michael Stur, professor at the Medical University of Vienna. “I believe having this innovative, sustained release drug available to my patients will prove to be beneficial in the long-term management of their condition.”
In July 2010, the Marketing Authorization Application (MAA) was submitted to seven European countries via the DCP with the UK MHRA serving as the RMS. The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien for the treatment of DME. Based on a consensus arrived upon by the RMS and the CMS, the MHRA issued its Final Assessment Report that Iluvien is approvable. Iluvien has not been approved by the United States Food and Drug Administration.
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss.
Alimera Sciences Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.