Statistical Significance in Improvement
in Visual Acuity and Reduction in Systemic
Therapy
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the
development of sustained release drug delivery products for
treating eye diseases, today announced positive topline results
from its first Phase 3 clinical trial evaluating the safety and
efficacy of Medidur™ for the treatment of chronic noninfectious
uveitis affecting the posterior of the eye (posterior uveitis). The
129 patient, multi-center, randomized and double-blinded trial was
highly statistically significant in meeting its primary efficacy
endpoint of prevention of recurrence of disease at six months (p
less than 0.00000001; intent to treat analysis). Safety results
were positive. Only 10.9% more Medidur-treated eyes than control
eyes experienced an increase in intraocular pressure (IOP) above 21
mmHg through six months, which was reduced to 6.1% through the most
recent follow-up visits (some as long as 24
months).
In the Medidur trial, 87 eyes were
treated with Medidur, and 42 eyes were randomized to control and
received a sham injection.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/b42de5fa-ff6b-480d-8cbb-e6ce8138d393
At six-months of follow-up:
- 18.4% of Medidur-treated eyes compared to 78.6% of control eyes
had experienced recurrence of posterior uveitis (a statistically
significant p less than 0.00000001).
- 23.0% of Medidur-treated eyes compared to 4.9% of control eyes
showed improvement in visual acuity gaining 15 or more letters from
baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS)
Eye Chart (a statistically significant p = 0.011).
- 31.0% of control eyes compared to 4.6% of Medidur-treated eyes
had lost 15 or more letters from baseline on the ETDRS Eye Chart
for at least one observation (a statistically significant p less
than 0.0001).
- Of the 65 patients receiving systemic therapy (steroids,
immuno-suppressants and biologics) at baseline, 52.4% of control
patients compared to 18.2% of Medidur-treated patients were still
being administered systemic treatment (a statistically significant
p less than 0.01).
- 27.6% of Medidur-treated eyes compared to 16.7% of control eyes
had experienced an increase in intraocular pressure (IOP) above 21
mmHg for at least one observation.
- Of the 64 study eyes with a natural lens at baseline, 9.5% of
Medidur-treated eyes compared to 4.8% of control eyes had required
cataract surgery.
“The results of this Phase 3 trial are extraordinary. With a
single injection, Medidur showed the ability to control the
recurrence of posterior uveitis, improve visual acuity and prevent
vision loss,” said Dr. Glenn Jaffe, Duke University Robert
Machemer Professor of Ophthalmology and Chief of the Division of
Retinal Ophthalmology and principal investigator for this trial.
“The high level of statistical significance achieved in this trial
is dramatic and, along with the compelling benefit-risk ratio,
suggests an important treatment option for patients who are
typically treated with repeated systemic steroids,
immuno-suppressants or biologics, often facing recurring attacks of
the disease as well as systemic side effects.”
The IOP elevation results for Medidur compare favorably to the
Phase 3 trial results for ILUVIEN® for diabetic macular edema,
which comprises the same micro-insert as Medidur. Other safety
results were also positive. Through six months, 2.3% of
Medidur-treated eyes and no control eyes required an incisional
procedure to reduce IOP. Through the most recent follow-up,
3.4% of Medidur-treated eyes compared to 2.4% of control eyes
required an incisional procedure to reduce IOP.
“The results from this Phase 3 trial indicate that Medidur has
the opportunity to be an effective, safe and convenient treatment
for this blinding eye disease, avoiding the potentially serious
side-effects and administration compliance challenges of the cycles
of systemic steroids, immuno-suppressants and biologics now used to
treat the disease,” said Dr. Charles Foster, Clinical Professor of
Ophthalmology at Harvard Medical School and Founder and President
of the Massachusetts Eye Research and Surgery Institution. “The
ability to administer a three-year course of Medidur therapy for
posterior uveitis in a single, in-office injection could allow many
patients to significantly improve treatment outcomes and vision,
reduce side effects and drastically simplify patient compliance as
compared to current treatment alternatives.”
The primary endpoint of pSivida’s Phase 3 trial was prevention
of recurrence of disease at six months. All other efficacy and
safety data analyses were exploratory. Topline results and
exploratory analyses were all based on intent to treat
population.
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 uveitis. These are
randomized, sham injection-controlled, double-masked trials. The
primary endpoint of both trials is prevention of recurrence of
posterior uveitis at six months, with patients in both trials
followed for three years. The first Phase 3 Medidur trial, which
enrolled 129 patients in 16 centers in the U.S. and 17 centers
outside the U.S, achieved its primary efficacy endpoint with high
statistical significance (p less than 0.00000001; intent to
treat analysis). The second trial, which is still enrolling
patients, will enroll up to 150 patients in approximately 15
centers in India. Assuming favorable results from the second
Phase 3 trial, an NDA is anticipated in the first half of 2017.
pSivida plans to seek FDA approval of Medidur based on
six-month data from the two Phase 3 trials and a short-duration
utilization study of pSivida’s redesigned proprietary inserter,
together with data referenced from the Phase 3 trials of ILUVIEN
for DME.
About Medidur. Medidur is an injectable
micro-insert designed to treat posterior uveitis. Injected
into the back of the eye, it provides sustained release of 0.18 mg
of the corticosteroid flucinolone acetonide at a controlled rate
directly to the retina for three years. Medidur comprises the same
micro-insert as ILUVIEN® for DME. ILUVIEN has been approved in the
U.S. and 17 EU countries and is sold by pSivida’s licensee in the
U.S., 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 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 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 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 being independently developed,
is currently in pivotal Phase 3 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 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; 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 the second Medidur Phase 3 trial, timing of
filing and acceptance of the Medidur NDA and EU marketing approval
applications, if at all; ability to use 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.
The photo is also available at Newscom, www.newscom.com,
and via AP PhotoExpress.
Contact:
Beverly Jedynak
O: 312-943-1123
M: 773-350-5793
bjedynak@janispr.com
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