pSivida Announces Submission Of MAA For An Ophthalmic Product For Diabetic Macular Edema In Certain European Union Countries

Main Category: Eye Health / Blindness
Also Included In: Diabetes;  Regulatory Affairs / Drug Approvals
Article Date: 12 Jul 2010 - 5:00 PDT

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pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, announced that its licensee, Alimera Sciences (NASDAQ:ALIM) 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 a sustained 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.

pSivida continues to work to develop new products for the sustained release of drugs and proteins based on its existing and new technologies. Additionally, Pfizer and pSivida are collaborating to develop ophthalmic products based on pSivida technology. While the Company remains primarily focused in ophthalmology, pSivida is exploring other therapeutic areas.

Source:
pSivida Corp.

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