The US Food and Drug Administration (FDA) has cleared pSivida's Investigational New Drug (IND) application to treat posterior uveitis with injectable sustained-release micro-insert. pSivida can now move to Phase III trials, which will be in addition to the investigator-sponsored trial studying the same device for posterior uveitis announced last month. pSivida expects to have 300 participants enroll in the Phase III trials for the injectable sustained-release micro-insert.
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. It is an ocular inflammatory disease that affects one of the eye's layers. pSivida's injectable micro-insert to treat posterior uveitis is a tiny tube about the size of an eyelash that 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.
"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."
pSivida is headquartered in Watertown, Ma, and is currently focused on the treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. pSivida's most advanced product candidate, ILUVIEN®, which is licensed to Alimera Sciences, Inc. for the treatment of Diabetic Macular Edema (DME), has received marketing authorization for chronic DME considered insufficiently responsive to available therapies in the UK, France, Austria, and Portugal following a positive review by Austria, France, German, Italy, Portugal, Spain, and the UK under the Decentralized Procedure.
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