BUSINESS WIRE
WATERTOWN, Mass.--(BUSINESS WIRE)--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,” 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.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™.
ILUVIEN® for the treatment of Diabetic Macular Edema (DME), which is
licensed to Alimera Sciences, Inc., is pSivida’s most advanced product
candidate. It 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. Marketing authorization in the remaining
countries is anticipated in the coming months. An investigator-sponsored
clinical trial is ongoing for an injectable, bioerodible insert to treat
glaucoma and ocular hypertension. pSivida’s two FDA-approved products,
Retisert® and Vitrasert®, are implants that provide long-term, sustained
drug delivery to treat two other chronic diseases of the retina.
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
activities, events or developments that we intend, expect or believe may
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
ILUVIEN for DME in the U.S.; ability to attain profitability; exercise
by Pfizer of the Latanoprost Product option; further impairment of
intangible assets; fluctuations in operating results; decline in royalty
revenues; ability to find partners to develop and market products;
termination of license agreements; competition; market acceptance of
products and product candidates; reduction in use of products as a
result of future guidelines, recommendations or studies; ability to
protect intellectual property and avoid infringement of others’
intellectual property; retention of key personnel; product liability;
consolidation in the pharmaceutical and biotechnology industries;
compliance with environmental laws; manufacturing risks; risks and costs
of international business operations; credit and financial market
conditions; legislative or regulatory changes; volatility of stock
price; possible dilution; possible influence by Pfizer; ability to pay
any registration penalties; absence of dividends; and other factors
described in our filings with the Securities and Exchange Commission.
Given these uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. Our forward-looking
statements speak only as of the dates on which they are made. We do not
undertake any obligation to publicly update or revise our
forward-looking statements even if experience or future changes makes it
clear that any projected results expressed or implied in such statements
will not be realized.