Statistically Significant Reduction in
Recurrence of Disease and Statistically Significant Improvement in
Visual Acuity
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the
development of sustained release drug delivery products for
treating eye diseases, today announced positive top line results
from a Phase II investigator-sponsored study of pSivida’s Medidur
for uveitis affecting the posterior of the eye (posterior,
intermediate and pan-uveitis). Dr. Glenn J. Jaffe, Robert Machemer
Professor of Ophthalmology at Duke University School of Medicine in
Durham, NC, presented the top line results during an oral abstract
session at the American Society of Retina Specialists in Vienna,
Austria, reporting a statistically significant reduction in
recurrence of uveitis and a statistically significant improvement
in visual acuity in eyes treated with Medidur.
In the three-year, ongoing study, 11 participants with recurrent
non-infectious intermediate, posterior or pan uveitis were
randomized to receive a masked low or a high dose of Medidur.
(pSivida is studying only the low dose of Medidur in its Phase III
clinical trials.) Fellow eyes with uveitis were treated with
standard of care, which included steroid eye drops. At the most
recent follow-up visit reported, participants have been followed
for between 12 and 24 months.
Through the last follow-up visit reported, none of the eyes
treated with Medidur had any recurrence of uveitis, while fellow
eyes treated with standard of care averaged 2.33 recurrences. The
difference between treatment with Medidur and standard of care was
statistically significant (p=0.014).
Eyes treated with Medidur experienced a significant improvement
in visual acuity, gaining an average of 17 letters from baseline
letters at 12 months on the Snellen eye chart (p=0.014 at 12
months). At the last follow-up visit reported, the average gain
from baseline in Medidur-treated eyes was over 20 letters, while
eyes treated with standard of care declined an average of 10
letters.
The most common adverse event in study eyes was elevated
intraocular pressure (IOP). Through the last follow-up visit
reported, three study eyes developed elevated IOP and were treated
with eye drops, with filtering procedures subsequently performed in
two of these eyes. However, those two eyes still gained an average
of over 25 letters from baseline at the last observation. The study
remains masked as to the dosage so results cannot yet be separated
for the low and high doses of Medidur.
pSivida recently announced that at three months in its first
Phase III trial, which is testing only the low dose of Medidur,
only 4% more study eyes (2/3 of which received Medidur) experienced
elevated IOP than the fellow non-study eyes (none of which received
Medidur). Initial IOP elevation is an indication of the likelihood
of subsequent clinically significant IOP increases. The minimal
difference observed in elevated IOP in the assessment suggests
highly favorable results for a key safety measure of the trial, the
number of eyes that develop clinically significant increases in IOP
within 12 months of receiving Medidur relative to control eyes.
“The results in Dr. Jaffe’s study are very dramatic. The
efficacy of Medidur in controlling uveitis and restoring visual
acuity was spectacular. At the extreme, in addition to completely
arresting any recurrence of uveitis, Medidur restored vision to two
eyes that were legally blind at baseline, improving from 20:400 to
20:25 and from 20:500 to 20:40 at the last follow-up visit. We look
forward to the unmasking of the data to view the results for the
low dose of Medidur we are studying,” said Dr. Paul Ashton,
President and Chief Executive Officer of pSivida Corp.
About the Phase II Trial. The investigator-sponsored
Phase II study is evaluating the tolerability, safety and benefits
of high and low dose Medidur in recurrent non-infectious posterior,
intermediate or pan-uveitis. Eleven enrolled participants were
randomized to receive a masked low or a high dose of Medidur in the
worse eye. (Only the low dose is being studied in pSivida’s Phase
III trials.) Fellow eyes with uveitis are treated with standard of
care. Eyes are observed on the day of injection, on days 1, 7, 14,
28, then monthly for up to six months, then every three months for
18 additional months. For purposes of these results, all
participants were followed for a minimum of one year, with a mean
follow-up duration of 20.5 months. Because the study is ongoing,
the dose remained masked, and the results present aggregate data
for the low and high dose. Full top-line results of this Phase II
study have been submitted for publication.
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 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 the 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 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 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 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 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: 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/pSividaCorpFacebook:
https://www.facebook.com/pages/PSivida-Corp/544893792199562LinkedIn:
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https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/postsThe
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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