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$PSDV $3.50 pSivida (PSDV) Notes Alimera (ALIM) Entering ILUVIEN Labeling Discussions with FDA
pSivida Corp. (Nasdaq: PSDV) announced that its licensee Alimera Sciences (Nasdaq: ALIM) has entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN® for Diabetic Macular Edema (DME) and, as a result, reported its agreement with the FDA that the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting to discuss ILUVIEN for DME was no longer necessary.

Alimera reported that it plans to respond to the FDA’s October 2013 Complete Response Letter (CRL) in the first quarter of 2014 and intends to address the concerns raised regarding the facility at which ILUVIEN for DME is manufactured and to provide recent safety data from patients in the United Kingdom and Germany. Alimera reported that the FDA has indicated that new clinical trials will not be required in connection with the FDA’s review of ILUVIEN for DME prior to approval.

“We are very pleased with Alimera’s discussion with the FDA with respect to appropriate labeling for ILUVIEN for DME and next steps required to move it closer to an FDA approval,” said Paul Ashton, Ph.D., President and CEO of pSivida. “We look forward to a first quarter resubmission and, hopefully, approval of this product. If approved, we will be entitled to a $25 million milestone payment from Alimera and 20% of net profits (as defined) on sales of ILUVIEN for DME by Alimera in the U.S.”

ILUVIEN is approved and commercially available in the United Kingdom and Germany and slated to launch in France early next year. ILUVIEN is also approved in Austria, Portugal and Spain and pending approval in Italy. In addition, Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom as the Reference Member State for ten additional European Union country approvals through the Mutual Recognition Procedure. pSivida will be entitled to 20% of net profits (as defined) on sales of ILUVIEN for DME by Alimera in the EU on a country-by-country basis.
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