pSivida Corp. (PSDV) today announced the National Security Agency of Medicines and Health Products (L’Agence Nationale de Sécurité du Médicament et des Produits de Santé) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Dr. Paul Ashton, President and CEO of pSivida, commented:
We are pleased our product has received marketing authorization in France. We now have marketing authorization in four of the seven targeted EU countries,” said . “We look forward to ILUVIEN receiving approval in the three remaining CMS countries, Germany, Italy and Spain, in the coming months.
Great news but keep in mind that yesterday the pSivida’s partner, Alimera Sciences, disclosed an agreement for a $40 million equity financing for the development and commercialization of ILUVIEN®. Alimera reported that proposed financing is subject to customary closing conditions and shareholders approval.
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pSivida is a leader in the development of miniaturized, injectable, drug delivery systems. Company develops products to treat serious or life threatening diseases alone or in partnership with other companies. It has developed devices that are so small they are FDA approved to be administered into the eye and once administered they release their drug for months and years.