pSivida’s Durasert™ Three-year Treatment for Posterior Segment Uveitis Successfully Achieves Primary Efficacy Endpoint in...
June 13 2017 - 7:00AM
Highly Significant Difference Observed Between
Durasert and Control Group in Primary Efficacy Analysis of
Prevention of Uveitis Recurrence
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, today
announced the Company’s second Phase 3 trial of Durasert three-year
treatment for posterior segment uveitis achieved the trial’s
primary endpoint. The study involved 153 patients and the primary
endpoint was prevention of recurrence of posterior uveitis at six
months with patients continuing to be followed for 36 months.
Durasert three-year insert demonstrated a significant reduction in
the recurrence of posterior segment uveitis through six months;
21.8% of Durasert-treated patients had a recurrence compared to
53.8% of patients in the sham group (p<0.001).
“The data from this trial confirms previous
clinical research demonstrating our three-year Durasert insert for
posterior segment uveitis may significantly help patients suffering
from this devastating disease -- the third leading cause of
blindness," said Nancy Lurker, President and CEO of pSivida Corp.
“Our market research indicates strong interest in using the product
driven by the results of our first Phase 3 clinical trial. We
continue to expect the submission of the European Market
Authorization Application (MAA) by the end of June, and we remain
on track to also file a New Drug Application (NDA) with the FDA in
the calendar fourth quarter of 2017.”
Additional safety results from the trial
included:
- Intraocular pressure (IOP) elevation, which can lead to
glaucoma, was 2.4 and 1.3 mm Hg (mean) at six months (vs baseline)
for Durasert and sham, respectively.
- Patients requiring IOP-lowering therapy at any time during the
first six months follow-up were 41.6% for Durasert and 34.6% for
sham. No subject required IOP surgery during the first six months
of follow-up.
- In patients with a natural (phakic) lens at baseline, 4.9% in
the Durasert group required a cataract surgery through six months
compared to 8.6% in the sham group.
Posterior segment uveitis is a chronic,
non-infectious inflammatory disease affecting the posterior segment
of the eye, often involving the retina, which is believed to be a
leading cause of blindness in the developed and developing
countries. It affects 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 between 80,000 –
100,000 people. Today, 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.
“The results of the second Phase 3 study confirm
the efficacy and safety profile of the Durasert three-year insert
demonstrated in the first Phase 3 study. Consistent, durable
control of chronic posterior segment uveitis is a critical goal of
treatment. The three-year Durasert insert has the potential
to be the first product approved to help prevent the recurrence of
this devastating condition for up to three years with a single
intravitreal injection,” commented Dr. Jyotirmay Biswas, Professor
of Ophthalmology and Director of Uveitis & Ocular Pathology
Department, Sankara Nethralaya Ophthalmic Center, Tamil Nadu, India
and primary investigator of the study.
“Chronic posterior uveitis is challenging to
treat as the disease tends to wax and wane over time.
Durasert three-year insert is a single-injection office-based
treatment that can last 2-3 years. Therefore, it addresses the need
to help prevent recurrences over an extended time
period, rather than to treat them episodically, and may
represent an exciting new approach to manage these patients,” added
Dr. Glenn J. Jaffe, Robert Machemer Professor of
Ophthalmology at Duke University School of
Medicine in Durham, NC and one of the world’s leading
uveitis experts.
Conference Call Information
pSivida Corp. will host a live webcast and
conference call today, June 13th, at 4:30pm ET. Company management
will be joined by Dr. Glenn J. Jaffe, Robert Machemer
Professor of Ophthalmology at Duke University School of
Medicine in Durham, NC. The conference call may be
accessed by dialing (877) 312-7507 from
the U.S. and Canada, or (631) 813-4828 from
international locations. The conference ID is 36482967. A live
webcast, with accompanying slides, will be available on the
‘Investors’ section of the corporate website
at http://www.psivida.com, under ‘Resources’ and ‘Events and
Presentations.’
A replay of the call will be available
beginning June 13, 2017, at approximately 7:30pm
ET and ending on June 20, 2017, at 11:59pm ET. The
replay may be accessed by dialing (855) 859-2056 within
the U.S. and Canada or (404) 537-3406 from
international locations, Conference ID Number 36482967. A replay of
the webcast will also be available on the corporate website during
that time.
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered
in Watertown, MA, is a leader in the development of
sustained-release drug products for treating 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 directly 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,
Durasert™ 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 technology, Durasert™, to deliver drugs to
treat wet 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 needed
capital; fluctuations in our operating results; further impairment
of our intangible assets; successful commercialization of, and
receipt of revenues from, ILUVIEN® for diabetic macular edema
(“ILUVIEN”), which depends on Alimera’s ability to continue as a
going concern and the effect of pricing and reimbursement decisions
on sales of ILUVIEN; safety and efficacy results of the second
Durasert three-year uveitis Phase 3 clinical trial and the number
of clinical trials and data required for the Durasert three-year
uveitis marketing approval applications in the U.S. and EU; our
ability to file and the timing of filing and acceptance of the
Durasert three-year uveitis marketing approval applications in the
U.S. and EU; our ability to use data in a U.S. NDA from clinical
trials outside the U.S.; maintenance of European orphan designation
for Durasert three-year uveitis; our ability to successfully
commercialize Durasert three-year uveitis, if approved; potential
off-label sales of ILUVIEN for uveitis; consequences of
fluocinolone acetonide side effects; potential declines in
Retisert® royalties; our ability to develop Tethadur to
successfully deliver large biologic molecules and develop products
using it; efficacy and our future development of an implant to
treat severe osteoarthritis; 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; our dependence
on contract research organizations, vendors and investigators;
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 U.K.
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 Securities and Exchange
Commission. 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; 646-445-4800
Thomas Gibson – Media
tom@tomgibsoncommunications.com
201-476-0322
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