pSivida Corp., a leader in developing sustained release drug delivery products for treatment of back-of-the-eye diseases, announced yesterday that ILUVIEN® has been granted marketing authorization from the Austrian Agency for Health and Food Safety (Osterreichische Agentur fur Gesundheit und Ernahrungssicherheit, AGES). ILUVIEN® is used in the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered unsatisfactorily responsive to available therapies.
This marketing authorization comes on the heels of the completion of the Decentralized Regulatory Procedure. In this procedure the Medicines and Healthcare products Regulatory Agency in the United Kingdom delivered a positive outcome for ILUVIEN along with the six Concerned Members States of Austria, France, Germany, Italy, Spain, and Portugal. Austria gave ILUVIEN® its first national approval in the EU. Alimera expects further approvals to come soon and ILUVIEN® to be available in the EU by the end of 2012.
“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.”
The International Diabetes Federation estimates that approximately 750,000 people are currently living with diabetes in Austria, and Alimera estimates more than 40,000 people suffer from DME and could potentially benefit from the use of ILUVIEN®.
For more information, please visit www.psivida.com
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