Phase 3 trial of Medidur™ in Posterior Segment Uveitis Meets Enrollment Target
October 04 2016 - 7:00AM
Study is the Second of Two Ongoing Phase 3 Trials in
Support Of Product Registration in the US
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug technologies for eye diseases, announced
that its second Phase 3 trial of Medidur in chronic, non-infectious
posterior segment uveitis met its target enrollment of 150
patients. The trial is being conducted in clinical sites in India,
with the same study design and endpoints as the first Phase 3 trial
conducted in the US, EU and India. The results of both Phase 3
trials will support US product registration, with NDA submission
planned for the second half of 2017. Filing for EU registration
remains on track for the first calendar quarter of 2017.
“We are very pleased that the second Phase 3
trial of Medidur in posterior segment uveitis has met its patient
enrollment goal on target and as expected,” said Nancy Lurker,
President and CEO of pSivida Corp. “Both Phase 3 trials are
generating efficacy and safety data critical to regulatory filings
in support of product registration. Reaching today’s milestone
brings us a step closer to making Medidur available to thousands of
patients battling with recurrent episodes of ocular inflammation
and the prospect of losing vision irreversibly.”
This first Medidur trial met the primary
efficacy endpoint of prevention of recurrence of posterior segment
uveitis at six months in December 2015. Primary efficacy endpoint
readout in the second study is expected in the second half of
2017.
About Medidur. Medidur is
an injectable micro-insert designed to treat posterior segment
uveitis and provide sustained release of a corticosteroid,
fluocinolone acetonide, for three years. Injected into the back of
the eye in an office procedure, it provides sustained release of
0.18 mg of fluocinolone acetonide at a controlled rate directly to
the site of chronic inflammation.
About Posterior Segment
Uveitis. Non-infectious posterior segment uveitis is
a chronic inflammatory disease affecting the posterior segment of
the eye, often involving the retina. This condition is a leading
cause of blindness in developed countries. It afflicts people of
all ages, producing swelling and destroying eye tissues critical
for maintaining vision. In the US, posterior segment uveitis is
estimated to affect approximately 175,000 people, resulting in
approximately 30,000 cases of blindness, making it the third
leading cause of blindness in the US.
Patients with posterior segment 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 can have severe
side effects, including an increased risk of cancer. Medidur is
designed to deliver small amounts of steroid locally over a
sustained period in the eye resulting in potentially reduced
systemic exposure compared to systemic medications.
About Medidur Phase 3
Trials. pSivida is conducting two Phase 3 trials to
assess the safety and efficacy of Medidur for the treatment of
posterior segment uveitis. These are randomized, sham
injection-controlled, double-masked trials. The primary endpoint of
both trials is recurrence of posterior segment uveitis at six
months, with patients in both trials followed for three years. The
first Phase 3 Medidur trial, which is fully enrolled with 129
patients in 16 centers in the US and 17 centers outside
the US, met its primary efficacy endpoint with high
statistical significance. The second trial has met its target
enrollment goal of 150 patients and is being conducted in 15
centers in India.
About pSivida Corp. pSivida
Corp. (www.psivida.com), headquartered in Watertown, MA, is a
leader in the development of sustained release drug technologies
for eye diseases. pSivida has developed three of only four
FDA-approved sustained-release treatments for back-of-the-eye
diseases. The most recent, ILUVIEN®, a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, is currently sold in
the US and three 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 segment uveitis being independently
developed, is currently in pivotal Phase 3 clinical trials.
pSivida's pre-clinical development program is focused on using its
core platform technologies Durasert™ and Tethadur™ to deliver drugs
and biologics to treat wet and dry age-related macular
degeneration, glaucoma, osteoarthritis and other diseases. To learn
more about pSivida, please visit www.psivida.com and connect on
Twitter, LinkedIn, Facebook and Google+.
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. 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:
our ability to achieve profitable operations and access to capital;
fluctuations in our operating results; further impairment of our
intangible assets; declines in Retisert royalties; successful
commercialization of, and receipt of revenues from, ILUVIEN for
DME; potential off-label sales of ILUVIEN for DME; Alimera’s
ability to continue as a going concern; the effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; consequences
of fluocinolone acetonide side effects; the outcome of a dispute
with Alimera regarding commercialization expenses; safety and
efficacy results of the second Medidur Phase 3 trial; the number of
trials and data required for, and timing of filing and acceptance
of, the Medidur NDA and EU marketing approval applications, if at
all; maintenance of orphan designation for Medidur; performance by
CROs, vendors and investigators; our ability to use data in a US
NDA from trials outside the US; our ability to successfully
commercialize Medidur, if approved; any exercise by Pfizer of its
option with respect to the latanoprost product; our ability to
develop Tethadur to successfully deliver large biologic molecules
and develop products using it; efficacy and future development of a
severe OA implant by us; our ability to successfully develop
product candidates, initiate and complete clinical trials and
receive regulatory approvals; our ability to market and sell
products; the success of current and future license agreements;
termination or breach of current 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; effects of the potential UK exit
from the EU; 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 in light of 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.
Contact:
EVC Group
Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.com; dsherk@evcgroup.com
212.850.6020; 415.652.9100
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