pSivida Announces Top-Line Results from Investigator-Sponsored Phase II Study of Medidur™ for Uveitis to Be Reported Next W...
July 07 2015 - 11:15AM
Business Wire
Dr. Glenn J. Jaffe to Present at
33rd Annual Scientific Meeting of American Society of
Retina Specialists
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the
development of sustained release drug delivery products for
treating eye diseases, announced that top line results from an
investigator-sponsored, Phase II study of pSivida’s Medidur for
uveitis will be presented at the 33rd Annual Scientific Meeting of
the American Society of Retina Specialists (ASRS) meeting to be
held July 10-14 in Vienna, Austria. Dr. Glenn J. Jaffe, Robert
Machemer Professor of Ophthalmology at Duke University School of
Medicine in Durham, NC, who is conducting this study, will make the
presentation. He also serves as principal investigator in pSivida’s
first pivotal Phase III trial for Medidur for posterior uveitis,
which is currently underway.
The American Society of Retina Specialists, a non-profit
corporation, provides a scientific forum to promote the advancement
of vitreoretinal diseases and surgery to its more than 2,600
members in the United States, Puerto Rico and 59 countries.
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-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 first
trial is recurrence of posterior uveitis within one year. The last
scheduled visit for the last patient in this trial is in March
2016, and top-line data is expected in the second quarter of 2016.
The second trial will enroll up to 150 patients in approximately 15
centers in India. The primary endpoint of the second trial is
recurrence of posterior uveitis within six months. Patients in both
trials will be followed for three years. pSivida’s 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 a New Drug Application 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
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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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Martin E. Janis & Company, Inc.Beverly JedynakPresidentT:
312-943-1123M: 773-350-5793bjedynak@janispr.com
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