pSivida’s Injectable Sustained-Release Micro-Insert for Treatment of Uveitis Proceeding to Phase III Trials
July 24, 2012
Last week, pSivida Corp. (NASDAQ: PSDV) announced that the FDA had cleared its Investigational New Drug (IND) application to treat posterior uveitis with pSivida’s injectable sustained-release micro-insert.
pSivida’s injectable micro-insert to treat posterior uveitis is a tiny tube about the size of an eyelash. It releases the off-patent steroid fluocinolone acetonide at a consistent rate over a period of approximately 36 months. The micro-insert is injected into the back of the eye during an office visit through the use of a fine gauge needle.
The upshot of the FDA approval is that pSivida is now permitted to move directly to two Phase III trials to treat patients with posterior uveitis without the necessity of Phase I or Phase II trials. pSivida expects the Phase III trials will enroll a total of 300 patients, and would be in addition to the investigator-sponsored trial studying the same device for posterior uveitis that the company announced last month.
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