pSivida, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today it has been granted marketing authorization for ILUVIEN® from the National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, Infarmed) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered inadequately responsive to available therapies.
The company has been granted this marketing authorization after completing the Decentralized Regulatory Procedure (DCP) in the European Union. In the DCP, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, serving as the Reference Member State, gave a positive outcome for ILUVIEN concurrent with the six Concerned Members States of Austria, France, Germany, Italy, Portugal, and Spain.
“We are pleased our product has received marketing authorization in Portugal. We now have marketing authorization in three of the seven targeted EU countries,” said Dr. Paul Ashton, president and chief executive officer of pSivida. “We look forward to ILUVIEN receiving approval in the four remaining CMS countries, France, Germany, Italy and Spain, in the coming months.”
The International Diabetes Federation estimates that over 1,000,000 people live with diabetes in Portugal, as well as more than 55,000 people suffering from vision loss associated with DME, according to Alimera’s estimates.
ILUVIEN is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
For further information, please visit www.psivida.com
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