Alimera Sciences Inc., Alpharetta, Georgia-based biopharmaceutical company, has received the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé).marketing authorization for 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 French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
“Iluvien has now been granted marketing authorizations in four of the seven EU countries in which we have applied. We are continuing to work with regulatory authorities in Germany, Italy and Spain,” said Dan Myers, president and chief executive officer, Alimera Sciences. “It's an exciting year for Iluvien and a step forward for the many people with chronic diabetic macular edema.”
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.
“The approval of Iluvien in France represents a significant accomplishment in the fight against blindness caused by diabetes,” said Gisele Soubrane, MD, PhD., FEBO, FARVO, professor of Ophthalmology, Hotel Dieu de Paris, University Paris Descartes. “I have seen the impact that chronic diabetic macular edema has on my patients and am pleased that a new therapy option will be introduced for use when current treatments have failed.”
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.
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 III 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 (FDA).
Safety was assessed among those patients treated with Iluvien who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7 per cent of these patients by month 36, compared to 18.4 per cent in the full Iluvien treated patient population. By month 36, 3.6 per cent of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8 per cent in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1 per cent at month 36, with 87.3 per cent undergoing a cataract operation, compared to 81.7 per cent and 80.0 per cent, respectively, in the full patient population.
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. The severity of this blurring may range from mild to profound loss of vision. As the population of people with diabetes increases, it is anticipated that the annual incidence of diagnosed DME will increase.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.