pSivida Announces NDA for Medidur™ Now Planned Using Six-Month Efficacy Data from Both Phase III Trials; FDA Concurs
September 28 2015 - 7:15AM
Business Wire
Top-Line Data from First Trial Expected
December 2015
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the
development of sustained release drug delivery products for
treating eye diseases, announced that the Company now plans to file
a New Drug Application (NDA) for Medidur for posterior uveitis
based on six-month efficacy data for both Phase III trials. The
U.S. Food & Drug Administration (FDA) has advised pSivida that
this data will be acceptable for review by the agency. pSivida
previously planned to utilize 12-month efficacy data from the first
trial and six-month efficacy data from the second trial. As
six-month visits in the first trial will be completed this month,
top-line results from the first Phase III trial are now anticipated
to be reported in December 2015. Enrollment in the second Phase III
trial continues and is expected to be completed during the first
half of 2016, with an NDA anticipated in the first half of
2017.
“We are very pleased that the FDA has agreed to review an NDA
for posterior uveitis based on six-month efficacy data,” said Dr.
Paul Ashton, president and CEO of pSivida. “The primary end-point
of the Phase III trials is recurrence of disease, which in the
majority of patients occurs typically within six months. Our
analysis of the masked data from our first trial is consistent with
this. We believe therefore that six-month data from our two trials
will show safety and efficacy. We look forward to being able to
announce the top-line results from the first trial at the end of
this year.”
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 in 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 is estimated to affect 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 Medidur’s Phase III Trials. pSivida’s two Phase III
trials for Medidur are double-masked studies comparing injections
of Medidur to sham injections on a two-to-one basis. The primary
end point of both trials is recurrence of uveitis within six
months. The first trial is fully enrolled with 129 patients in 16
centers in the U.S. and 17 centers outside the U.S. The last
scheduled visit for the last patient in this trial is in September
2015, and top-line data is expected in December 2015. The second
trial will enroll up to 150 patients in approximately 15 centers in
India. Patients in both trials will be followed for three years.
pSivida plans to seek approval for Medidur for posterior uveitis
based on six-month data from the two trials 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 a New Drug
Application in the first half of 2017.
About pSivida Corp. pSivida Corp., 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 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 uveitis, is currently in pivotal Phase
III clinical trials with an NDA anticipated in the first half of
2017. pSivida’s pre-clinical 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. 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; further impairment of
our intangible assets; fluctuations in our operating results;
declines in Retisert royalties; successful commercialization of,
and receipt of revenues from, ILUVIEN for DME; the effect of
pricing and reimbursement decisions on sales of ILUVIEN for DME;
consequences of flucinolone acetonide side effects; safety and
efficacy results of Medidur Phase III trials, timing of filing and
acceptance of the Medidur NDA, if at all; fluctuations in our
operating results; ability to use of data in a U.S. NDA from trials
outside the U.S.; 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; 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; 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.
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Martin E. Janis & Company, Inc.Beverly Jedynak,
312-943-1123PresidentM: 773-350-5793bjedynak@janispr.com
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