While U.S. marketing approval appears to be out of reach for Alimera and pSivida for Iluvien for the sustained release treatment of diabetic macular edema, the first of six expected approvals for Europe has been obtained. The companies announced that the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) had granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The Austrian authorization is the first national approval in the EU. Additional Concerned Members States (CMS) marketing authorizations are expected in the coming months.
Here is the pertinent information released from both Alimera and pSivida:
Iluvien Receives Marketing Authorization in Austria for the Treatment of Chronic Diabetic Macular Edema
ATLANTA, April 24, 2012 - Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) had granted marketing authorization 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 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.
"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 percent 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 percent 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."
pSivida, which licenses the drug delivery system to Alimera added the following information: "We are very pleased Iluvien has received this marketing authorization and will soon be available to patients in Austria," said Dr. Paul Ashton, president and chief executive officer of pSivida . We look forward to Iluvien receiving the additional expected EU approvals."