FDA clears pSivida's IND for injectable sustained-release micro-insert to treat posterior uveitis

Jul 20 2012

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) 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.

“We are very pleased to be cleared to commence phase III clinical trials for the treatment of this blinding disease without the necessity of Phase I or Phase II trials”

"We are very pleased to be cleared to commence phase III clinical trials for the treatment of this blinding disease without the necessity of Phase I or Phase II trials," said Dr. Paul Ashton, President and CEO of pSivida Corp. "Importantly, the FDA has agreed that the primary end point in these trials will be recurrence of uveitis within 12 months and that we can reference much of the data, including the clinical safety data, from the clinical trials for ILUVIEN® for Diabetic Macular Edema (DME) conducted by our collaborative partner Alimera Sciences, Inc. (Alimera). We appreciate the input provided by the FDA about the design of these trials and believe these design features will be advantageous in terms of cost and time.

"Because the micro-insert delivers the same drug as our approved Retisert® product for posterior uveitis, we expect to these trials will show efficacy. Further, as the same micro-insert was used in the ILUVIEN trials, we expect to observe a comparable side-effect profile in uveitis patients as was seen in DME patients. As a result, we are optimistic that our micro-insert will be efficacious for posterior uveitis with a favorable risk/benefit profile and fewer side effects than Retisert."

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.