Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in
research, development and commercialization of prescription
ophthalmic pharmaceuticals, and Knight Therapeutics Inc. (TSX:GUD)
(Knight), a leading Canadian specialty pharmaceutical company,
today announced that Knight’s New Drug Submission (NDS) for
ILUVIEN® has been accepted for review by Health Canada. ILUVIEN
(fluocinolone acetonide intravitreal implant) 0.19 mg is Alimera's
sustained release intravitreal implant approved in
the U.S. to treat diabetic macular edema (DME) in
patients who have been previously treated with a course of
corticosteroids and did not have a clinically significant rise in
intraocular pressure.
“ILUVIEN is a unique and innovative product that is available in
different markets around the world, including the U.S. and Europe,”
said Jonathan Ross Goodman, CEO of Knight. “We are happy to
continue advancing ILUVIEN and our portfolio of novel therapeutics
that improve the health of Canadian patients.”
“This is another important milestone for ILUVIEN,” said Dan
Myers, CEO of Alimera. “We believe ILUVIEN is the only therapy that
treats DME consistently every day due to its continuous microdosing
for up to three years, and we look forward to working with Knight
and Health Canada to make ILUVIEN available to Canadian
patients.”
Knight and Alimera signed an agreement in July 2015 granting
Knight the exclusive right to distribute ILUVIEN in Canada.
About ILUVIEN
www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant approved in
the U.S. to treat diabetic macular edema in patients who
have been previously treated with a course of corticosteroids and
did not have a clinically significant rise in intraocular pressure.
Each ILUVIEN implant is designed to release submicrogram levels of
fluocinolone acetonide, a corticosteroid, for 36 months.
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 research, development and commercialization
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.
Alimera 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 plans to make
ILUVIEN available to Canadian patients. 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, Knight’s ability to obtain
approval from Health Canada and to launch ILUVIEN in Canada, 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, 2015 and Quarterly Report
on Form 10-Q for the quarters ended June 30, 2016 and
September 30, 2016, 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 also be set forth in those sections of Alimera's Annual Report
on Form 10-K for the year ended December 31, 2016, to be filed
with the SEC in the first quarter of 2017. 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.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is
a specialty pharmaceutical company focused on acquiring or
in-licensing innovative pharmaceutical products for the Canadian
and select international markets. Knight's shares trade on TSX
under the symbol GUD. For more information about Knight, please
visit the company's web site at www.gud-knight.com or
www.sedar.com.
Knight Forward-Looking Statement
This document contains forward-looking statements for Knight
Therapeutics Inc. and its subsidiaries. These forward looking
statements, by their nature, necessarily involve risks and
uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Knight
Therapeutics Inc. considers the assumptions on which these
forward-looking statements are based to be reasonable at the time
they were prepared, but cautions the reader that these assumptions
regarding future events, many of which are beyond the control of
Knight Therapeutics Inc. and its subsidiaries, may ultimately prove
to be incorrect. Factors and risks, which could cause actual
results to differ materially from current expectations are
discussed in Knight Therapeutics Inc.'s Annual Report and in Knight
Therapeutics Inc.'s Annual Information Form for the year ended
December 31, 2015. Knight Therapeutics Inc. disclaims any intention
or obligation to update or revise any forward-looking statements
whether as a result of new information or future events, except as
required by law.
For Alimera Sciences:
Katie Brazel
404-317-8361
kbrazel@bellsouth.net
For Knight Therapeutics:
Jeffrey Kadanoff, P.Eng., MBA
Chief Financial Officer
514-484-GUD1 (4831)
info@gud-knight.com
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