Positive Results Enable Alimera Sciences to Reduce Enrollment in ILUVIEN® Registry Safety Study in the U.K.
July 19 2017 - 4:05PM
Positive consistent results spur move to
cap study at 550 patientsEnrollment complete as of
January 2017
Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the
commercialization, research and development of prescription
ophthalmic pharmaceuticals, today announced that the United
Kingdom's Medicines and Healthcare Products Regulatory Agency
(MHRA) has given final approval to reduce the size of its ILUVIEN
Registry Safety Study (IRISS).
A post-marketing study, IRISS was originally designed to follow
800 ILUVIEN patients over five years. However, consistently
positive real-world safety data from IRISS and other post-marketing
studies led Alimera to seek a smaller sample size. Alimera enrolled
the 550th patient in January of this year, making the anticipated
last patient, last visit date January 2020.
"We are very pleased to receive final approval from MHRA to
complete enrollment in IRISS as it stands today," said Dan Myers,
CEO of Alimera. "Since the beginning, the results we've seen in our
post-marketing studies have mirrored, and often exceeded, the
results in our FAME™ clinical trials. From this, we concluded that
we could potentially reduce the IRISS sample size without
compromising on the study objective, and MHRA agreed. In addition
to cost and time savings, our ability to produce data sets on
safety, efficacy and disease burden reduction earlier than expected
allows us to share this data with our customers."
About ILUVIEN
www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant indicated in the E.U. to
treat vision impairment associated with chronic DME considered
insufficiently responsive to available therapies. Each ILUVIEN
implant with its continuous microdosing is designed to release
submicrogram levels of fluocinolone acetonide, a corticosteroid,
for 36 months, enabling the physician to treat the disease
consistently every day.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic
retinopathy, is a disease affecting the macula, the part of the
retina responsible for central vision. When the blood vessel
leakage associated with diabetic retinopathy results in swelling of
the macula, the condition is called DME. The onset of DME is
painless and may go unreported by the patient until it manifests
with the blurring of central vision or acute vision loss. The
severity of this blurring may range from mild to profound loss of
vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy
found that over a 10-year period approximately 19% of people with
diabetes included in the study were diagnosed with DME. All people
with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company
that specializes in the commercialization, research, and
development of prescription ophthalmic pharmaceuticals. Alimera is
presently focused on diseases affecting the back of the eye, or
retina, because these diseases are not well treated with current
therapies and will affect millions of people in our aging
populations. Alimera’s commitment to retina specialists and their
patients is manifest in Alimera’s product and development portfolio
designed to treat early- and late-stage diseases. For more
information, please visit www.alimerasciences.com.
Forward Looking Statements
This press release contains “forward-looking statements,” within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, the results of our
post-marketing studies of ILUVIEN, the expected timing of the last
patient visit for IRISS and the benefits to be realized from the
reduced patient enrollment in IRISS. Such forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual results to differ
materially from those projected in its forward-looking statements.
Meaningful factors which could cause actual results to differ
include, but are not limited to, the ability of the reduced
enrollment in IRISS to yield results consistent with the FAME™
clinical trials, our ability to capture the anticipated cost
savings from the smaller sample size and our ability to accelerate
the completion of IRISS, as well as other factors discussed in the
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of
Alimera’s Annual Report on Form 10-K for the year
ended December 31, 2016 and Quarterly Report on Form 10-Q for
the quarter ended March 31, 2017, which are on file with
the Securities and Exchange Commission (SEC) and
available on the SEC’s website at www.sec.gov.
Additional factors may be set forth in those sections of Alimera's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017,
to be filed in the third quarter of 2017 with the SEC. In addition
to the risks described above and in Alimera’s Annual Report on Form
10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K
and other filings with the SEC, other unknown or unpredictable
factors also could affect Alimera’s results. There can be no
assurance that the actual results or developments anticipated by
Alimera will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on,
Alimera. Therefore, no assurance can be given that the outcomes
stated in such forward-looking statements and estimates will be
achieved.
All forward-looking statements contained in this press release
are expressly qualified by the cautionary statements contained or
referred to herein. Alimera cautions investors not to rely too
heavily on the forward-looking statements Alimera makes or that are
made on its behalf. These forward-looking statements speak only as
of the date of this press release (unless another date is
indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
For press inquiries:
Katie Brazel
for Alimera Sciences
404-317-8361
kbrazel@bellsouth.net
For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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