Data Safety Monitoring Board Recommends Continuation of pSivida's (PSDV) Phase III Trials for Iluvien
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pSivida Corp. (NASDAQ: PSDV) today reported that an independent Data Safety Monitoring Board has recommended the continuation of two pivotal Phase III clinical trials for the use of Iluvien™ (formerly known as Medidur FA™) in the treatment of diabetic macular edema under the current protocol, without change. The clinical trials are being conducted by the company’s licensing partner, Atlanta-based Alimera Sciences, Inc. Top line data from the trials is expected to be available at the end of this year.
The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.
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