Alimera Sciences Announces ILUVIEN® Now Available In U.K.
ATLANTA, April 29, 2013
-- Simple Patient Access Scheme has been submitted to NICE for rapid review
ATLANTA, April 29, 2013 /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research,
development and commercialization of prescription ophthalmic pharmaceuticals,
today announced that ILUVIEN ^® , the first sustained release pharmaceutical
product for the treatment of chronic diabetic macular edema (DME), is now
available in the United Kingdom.
In addition, Alimera Sciences has recently submitted a simple Patient Access
Scheme (PAS) to the United Kingdom's National Institute for Health and Care
Excellence (NICE) for consideration of the guidance under rapid review. The
NICE Appraisal Committee will assess the likely impact of the ILUVIEN PAS and
determine whether an update to NICE's previously issued final guidance is
warranted. If the PAS is accepted by NICE, it is anticipated that ILUVIEN
would be funded for chronic DME patients in England and Wales through the
National Health Service (NHS).
"I am pleased to be able to finally offer this new sustained release treatment
to my private pay and privately insured patients, who suffer from vision
impairment associated with chronic DME," said Simon Horgan, FRCS, FRCOphth,
consultant ophthalmic surgeon at St. George's Hospital, Tooting, and
Moorfields Eye Hospital, London. "ILUVIEN is a welcome option for DME
patients, who no longer respond to conventional therapies and who are facing
progression to blindness. I am hoping that in the near future many more
patients who are likely to benefit from this treatment will be offered
The NICE Appraisal Committee is scheduled to meet on May 15, 2013 to discuss
the ILUVIEN PAS submission with an expected 30-day review period to follow.
"We are pleased that ILUVIEN is now available in the U.K.," said Dan Myers,
president and chief executive officer, Alimera Sciences. "We continue to work
with NICE and are hopeful that our simple Patient Access Scheme will make
ILUVIEN available to a larger group of chronic DME patients in England and
Wales, who are considered insufficiently responsive to available therapies."
Diabetic macular edema (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 of
diabetic retinopathy causes swelling in the macula, the condition has
progressed to DME. The onset of DME is painless and may go undetected 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. As the population of people with diabetes increases, it is anticipated
the annual incidence of diagnosed DME will increase.
About ILUVIEN ^®
ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained
release intravitreal implant used to treat vision impairment associated with
chronic DME considered insufficiently responsive to available therapies. Each
ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering
sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is
injected in the back of the patient's eye to a position that takes advantage
of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle,
which allows for a self-sealing wound.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to
seven European countries via the Decentralized Procedure (DCP) with the
Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving
as the Reference Member State (RMS). The MAA included data from two Phase 3
pivotal clinical trials (collectively known as the FAME™ Study) for ILUVIEN
conducted by Alimera. The trials involved 956 patients in sites across the
United States, Canada, Europe and India to assess the efficacy and safety of
ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was
reached by the RMS and the other six countries that the MAA for ILUVIEN was
approvable. To date, six of the seven countries, Austria, the United Kingdom,
Portugal, France, Spain and Germany have granted national licenses for
ILUVIEN. The national phase in Italy is ongoing. ILUVIEN has not been approved
by the United States Food and Drug Administration.
Clinical trial data from the FAME Study showed that in patients with chronic
DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients
experienced an improvement from baseline in their best corrected visual acuity
on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15
letters or more. At the completion of the 36-month study, 34 percent had
achieved the same result. This effect was highly statistically significant
(p<0.001) as compared to the sham control group, which received laser and
other intravitreally administered therapies.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical
company that specializes in the research, development and commercialization of
prescription ophthalmic pharmaceuticals. Presently Alimera is focused on
diseases affecting the back of the eye, or retina. Its primary product,
ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a
non-proprietary corticosteroid with demonstrated efficacy in the treatment of
About the Rapid Review Facility
Patient access schemes are designed to maximize the opportunity for access to
a new technology. Therefore, within 16 weeks of guidance publication, a rapid
review facility is available to consider new patient access schemes. NICE can
only consider these schemes after ministerial approval and confirmation by the
United Kingdom's Department of Health. After approval, the rapid review of the
guidance is planned, as a priority, into the work program. The Appraisal
Committee will usually consider the scheme within six months of referral of
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, Alimera's commercial plans for ILUVIEN in the United Kingdom.
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,
NICE's acceptance of the Patient Access Scheme, uncertainty as to Alimera's
ability to commercialize, and market acceptance of, ILUVIEN in the United
Kingdom, 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, 2012, which is on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at www.sec.gov .
Additional factors may also be set forth in those sections of Alimera's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 to be filed
with the SEC in the second quarter of 2013. 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
UKILV-0014. Date of Preparation April 2013.
For press inquiries: For investor inquiries:
Katie Brazel, Fleishman-Hillard John Mills, ICR
for Alimera Sciences for Alimera Sciences
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