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+:
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The President's Blog:
http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20150519005734/en/
Martin E. Janis & Company, Inc.Beverly Jedynak,
312-943-1123PresidentM: 773-350-5793bjedynak@janispr.com
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