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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

+14.0%

Mar 29 4:00 PM EDT

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From: John McCarthy	12/28/2010 9:52:10 AM
	of 421

<snip> has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®. Iluvien,developed by pSivida and licensed to Alimera Sciences in 2005, is asustained release drug delivery system releasing the steroid flucocinolone acetonide for the treatment of diabetic macular edema (DME). The MAA is being submitted through the Decentralized Procedure with the UK MHRA as the Reference Member State (RMS). Applications have also been submitted to the following other Concerned Member States (CMS) in the European Union: Austria, France, Germany, Italy, Portugal and Spain. This submission closely follows the submission last week of the NDA to the U.S. Food and Drug Administration for approval for Iluvien to treat DME. The MAA submission includes the 24 month low dose data from the FAME study. Alimera has indicated it plans to follow this MAA submission with a registration filing in Canada in the near future. pSivida has joint ownership and reference rights to the MAA and NDA. theladiesconnection.com

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