pSivida (PSDV) Wins FDA Clearance for Pivotal Trials on Injectable Sustained-Release Micro-Insert for Uveitis

July 19, 2012 8:08 AM EDT
pSivida Corp. (NASDAQ: PSDV) announced the FDA has cleared its Investigational New Drug application to treat posterior uveitis with pSivida’s injectable sustained-release micro-insert. pSivida is now permitted to move directly to two Phase III trials to treat patients with posterior uveitis. These trials, which pSivida expects would enroll a total of 300 patients, would be in addition to the investigator-sponsored trial studying the same device for posterior uveitis announced last month.

Posterior uveitis is an inflammatory disease of one of the layers of the eye. In the U.S. posterior uveitis affects approximately 175,000 people and is responsible for approximately 30,000 cases of blindness, making it the third largest cause of blindness.

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 same micro-insert has recently received marketing authorization for chronic DME considered insufficiently responsive to available therapies in the UK, Austria, France and Portugal following a positive review under the Decentralized Procedure. Marketing authorization in the remaining countries is anticipated in the coming months. Alimera has reported that it expects the insert, to be marketed under the name ILUVIEN, to be the first sustained-release pharmaceutical in the EU to treat DME.

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