Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, has received marketing authorization from the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) for its 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 Spanish authorization is the sixth national approval in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany.

"Iluvien has now been granted marketing authorizations in six of the seven EU countries in which we have applied," said Dan Myers, president and chief executive officer, Alimera. Myers further added, "With our European management team now on board, we are looking forward to the initial commercial launch of Iluvien in Germany, expected during the first quarter of 2013. In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy."

The International Diabetes Federation estimates that more than three million people are currently living with diabetes in Spain, approximately 160,000 of whom Alimera estimates 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 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.

"As ophthalmologists, we've been limited in our ability to provide relief for chronic diabetic macular edema patients when existing therapies have stopped working," said José Maria Ruiz Moreno, professor of Ophthalmology, University of Castilla La Mancha. "With its approval, Iluvien covers an important gap in the range of treatment options for chronic diabetic macular edema, and it becomes a source of hope for patients who face the threat of blindness."

Iluvien (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected 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 Alimera's FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.

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.