pSivida Corp. Receives FDA Clearance for Pivotal Trials for Injectable Sustained-Release Micro-Insert to Treat Uveitis
"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.
"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
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SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are
forward-looking, and are inherently subject to risks, uncertainties and
potentially inaccurate assumptions. All statements that address
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occur in the future are forward-looking statements. The following are
some of the factors that could cause actual results to differ materially
from the anticipated results or other expectations expressed,
anticipated or implied in our forward-looking statements: necessity to
raise additional capital to finance Phase III uveitis trials as well as
other working capital needs; ability to obtain additional capital;
ability to initiate and complete clinical trials and obtain regulatory
approval of product candidates; adverse side effects; Alimera's ability
to successfully obtain regulatory approval of and commercialize ILUVIEN
for DME in the EU; actions with respect to regulatory approval of
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+1 (312) 943 1123
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(0) 41 228 1780
brianl@psivida.com
Source:
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