WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV); (ASX:PVA), a leader in the development of
sustained release drug delivery products for treating eye diseases,
today announced positive safety data from its ongoing assessment of
masked safety data from its first Phase III clinical trial of Medidur™
for posterior uveitis, a blinding eye disease. At three months, only 4%
more study eyes (2/3 of which received Medidur) experienced elevated
intraocular pressure (IOP) than the fellow non-study eyes (none of which
received Medidur). Initial IOP elevation is an indication of the
likelihood of subsequent clinically significant IOP increases. The
minimal difference observed in elevated IOP in the assessment suggests
highly favorable results for a key safety measure of the trial, the
number of eyes that develop clinically significant increases in IOP
within 12 months of receiving Medidur relative to control eyes.
"These data are very encouraging for the safety profile of Medidur,"
said Dr. Paul Ashton president and CEO of pSivida Corp. "A significant
treatment challenge with posterior uveitis patients is managing the
serious side effects of prolonged steroid use, the current first-line
treatment. A therapy that can provide the benefits of steroids on a
sustained basis for three years with a single injection with a lower
incidence of side effects would be a very significant advance in
treatment of this disease."
The assessment of masked data compared the elevation of IOP over 21mmHg
at three months study eyes and fellow eyes for the 105 out of 129
enrolled subjects with at least three month follow-up data.
"We are very optimistic for the final IOP safety results in this trial,"
said Dr. Ashton. "We originally expected that the final IOP safety
profile for Medidur would be at least as good as the IOP safety profile
of the FDA-approved ILUVIEN® for diabetic macular edema (DME) (which
uses the same micro-insert as Medidur and delivers the same dose of the
same drug), and much better than the IOP safety profile of the
FDA-approved Retisert® (which delivers a higher dose of the same drug in
Medidur). On the basis of this ongoing assessment of masked study safety
data, we now believe the final IOP results in the Medidur trial could be
even better than those shown in the ILUVIEN and Retisert Phase III
trials. At 36 months, 24% more patients treated with ILUVIEN and 45%
more patients treated with Retisert required medication for elevated IOP
than controls in their Phase III trials. We expect top line results from
this first Phase III trial of Medidur to be available in Q2 2016, and
with favorable results from this and our second trial, which has just
been initiated, we intend to file for U.S. approval in the first half of
2017."
About Medidur. Medidur is an injectable micro-insert designed to
treat posterior uveitis that provides sustained release of flucinolone
acetonide (a corticosteroid) for three years. Medidur comprises the same
micro-insert (same design, same polymers, same drug, same dose) as
ILUVIEN for DME. ILUVIEN has been approved in the U.S. and 17 EU
countries and is sold the U.S., the U.K., Germany and Portugal.
About Posterior Uveitis. Posterior uveitis is a chronic,
non-infectious inflammatory disease affecting the posterior segment of
the eye, often involving the retina, which is a leading cause of
blindness in the developed and developing countries. It afflicts people
of all ages, producing swelling and destroying eye tissues, which can
lead to severe vision loss and blindness. In the U.S., posterior uveitis
affects approximately 175,000 people, resulting in approximately 30,000
cases of blindness and making it the third leading cause of blindness in
the U.S.
Patients with posterior uveitis are typically treated with systemic
steroids but over time frequently develop serious side effects that can
limit effective dosing. Patients then often progress to steroid-sparing
therapy with systemic immune suppressants or biologics, which themselves
can have severe side effects including an increased risk of cancer.
Medidur is designed to provide improved outcomes compared to standard of
care but with a significant reduction in side effects.
About the Phase III Trials. The two Phase III clinical trials are
double-blind studies comparing injections of Medidur to sham injections
on a two-to-one basis. The first trial is fully enrolled with 129
patients in 16 centers in the U.S. and 17 centers outside the U.S. The
primary end point of the trial is recurrence of posterior uveitis within
one year. The last scheduled visit for the last patient will be in March
2016, and top-line data is expected in the second quarter of 2016. The
second trial will enroll up to150 patients in approximately 15 centers
in India. The primary endpoint will be recurrence of posterior uveitis
within six months. Patients in both trials will be followed for three
years. pSivida plans to seek approval for Medidur for posterior uveitis
based on 12-month data from the first Phase III trial, six-month data
from the second phase III trial and data from a utilization study of
pSivida's redesigned proprietary inserter together with data referenced
from the Phase III trials of ILUVIEN for DME. With favorable results,
pSivida expects to file an NDA in the first half of 2017.
About pSivida Corp.
pSivida Corp. (www.psivida.com),
headquartered in Watertown, MA, is a leader in the development of
sustained release, drug delivery products for treating eye diseases.
pSivida has developed three of only four FDA-approved treatments for
back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for
diabetic macular edema, is licensed to Alimera Sciences and sold in the
U.S. and four EU countries. Retisert®, an implant for posterior
uveitis, is licensed to and sold by Bausch & Lomb. pSivida's lead
product candidate, Medidur™, a micro-insert for posterior uveitis, is
currently in pivotal phase III clinical trials with an NDA anticipated
in the first half of 2017. pSivida's preclinical development program is
focused on using its core platform technologies, Durasert™ and/or
Tethadur™, to deliver drugs and biologics to treat wet and dry
age-related macular degeneration (AMD), glaucoma, osteoarthritis and
other diseases.
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 statement 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 include uncertainties with
respect to: actual final IOP safety results for Medidur Phase III
trials; ability to achieve profitable operations and access to capital;
fluctuations in operating results; further impairment of intangible
assets; decline in Retisert royalties; successful commercialization of,
and receipt of revenues from, ILUVIEN for DME; effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; consequences of
fluocinolone acetonide side effects; number and cost of clinical trials
and data necessary to support an NDA for, approval by Indian regulators
of the trial design for, timing of filing the NDA for, and regulatory
approval and successful commercialization of, Medidur; delays in
completion of clinical trials; increases in cost of clinical trials;
changes in, or misunderstandings with respect to, FDA guidance on
required clinical trials; development of the Latanoprost Product and any
exercise by Pfizer of its option; ability of Tethadur to successfully
deliver large biologic molecules and to develop products using it;
ability to successfully develop product candidates, complete clinical
trials and receive regulatory approvals; ability to market and sell
products; success of current and future license agreements; termination
of license agreements; effects of competition and other developments
affecting sales of products; market acceptance of products; effects of
guidelines, recommendations and studies; protection of intellectual
property and avoiding intellectual property infringement; retention of
key personnel; product liability; industry consolidation; compliance
with environmental laws; manufacturing risks; risks and costs of
international business operations; legislative or regulatory changes;
volatility of stock price; possible dilution; absence of dividends; and
other factors described in our filings with the SEC. You should read and
interpret any forward-looking statements together with these risks.
Should known or unknown risks materialize, or should underlying
assumptions prove inaccurate, actual results could differ materially
from past results and those anticipated, estimated or projected in the
forward-looking statements. You should bear this in mind as you consider
any 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.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150519005734/en/
Martin E. Janis & Company, Inc.
Beverly Jedynak, 312-943-1123
President
M:
773-350-5793
bjedynak@janispr.com
Source: pSivida Corp.
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