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Biotech / Medical : PSDV - pSivida Limited
PSDV 1.220+14.0%Mar 29 5:00 PM EST

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To: John McCarthy who wrote (181)9/27/2009 3:07:06 PM
From: John McCarthy  Read Replies (1) of 421
 
P#5 - pSivida Ltd. Reports Operating Results (10-K)
gurufocus.com

gurufocus.com

SEVERE EDIT - SELECTION - REARRANGEMENT

We licensed Alimera the rights to develop, market and sell Medidur FA, which Alimera intends to commercialize under the name Iluvien.

Alimera is conducting fully enrolled Phase III trials for Iluvien.

Alimera expects that 24-month data from these clinical trials will be available in late 2009, and plans to file an NDA with the FDA in early 2010.

Under our collaboration agreement, Alimera is also studying Iluvien in three investigator-sponsored pilot clinical trials.

One trial is designed to assess the safety and efficacy of Iluvien in conjunction with Lucentis in patients with exudative age-related macular degeneration (wet AMD) to provide information on the potential of Iluvien to maintain the efficacy of Lucentis while reducing the overall number of Lucentis treatments.

A second trial is designed to assess the safety and efficacy of Iluvien in patients with bilateral geographic atrophy secondary to dry-AMD.

The third trial is designed to assess the safety and efficacy of Iluvien in patients with macular edema secondary to retinal vein occlusion.

Other Technology Applications. We have a worldwide collaborative research and license agreement with Pfizer under which Pfizer may develop certain ophthalmic applications of Medidur-based products that are not licensed to Alimera. In addition, we are conducting pre-clinical studies utilizing our Durasert technology designed to treat glaucoma and retinitis pigmentosa.
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