First approved treatment of its class for the most-feared complication
of diabetes and a leading cause of vision loss in working-aged adults
DORVAL, QC, Sept. 14, 2011 /CNW Telbec/ - Health Canada has approved
Lucentis* (ranibizumab) as a treatment for vision loss resulting from
diabetic macular edema (DME), one of the major causes of adult vision
loss and an important complication of the growing epidemic of diabetes.1
For diabetics, the possibility of losing their eyesight is the most
feared complication of their diabetes. Visual impairment due to DME
reduces patients' quality of life by compromising various activities
such as ability to work, read and drive.2 DME is a consequence of diabetic retinopathy which usually progresses
slowly with worsening symptoms and impact on vision.3
An estimated 2.5 million Canadians have diabetes. And like its parent
disease, the sight-robbing condition DME does not discriminate against
age. In fact, of the more than 70,000 Canadians whose vision is
currently affected by DME, a significant number are of working age,
with a recent study enrolling patients as young as 30.4
Laser therapy, the current standard of care, has provided stabilization
of vision in many patients, but generally does not improve vision.
Lucentis* is the first approved therapy to improve vision for patients
with visual impairment due to DME.
"Lucentis* provides us for the first time a real opportunity to improve
vision in persons with DME," said Dr. Peter Kertes, a vitreo-retinal
surgeon and Ophthalmologist-in-chief of the John and Liz Tory Eye
Centre at Sunnybrook Health Sciences Centre and Associate Professor in
the Department of Ophthalmology and Vision Sciences at the University
of Toronto. He was also an investigator in the studies that were
reviewed by Health Canada for the approval of Lucentis* for this
condition. "In one study, after 12 months a significantly greater
proportion of patients treated with Lucentis* had vision in the treated
eye at or above the international legal minimum for driving. This is a
major achievement that has a meaningful impact on patients' lives."
One of the Canadian patients in the international trials studying
Lucentis* in DME was Kash Joshi of Toronto. Diagnosed with diabetes in
1994, several years ago he started having troubles with blurry vision,
which continued even after cataract surgery, at which point he enrolled
in the Lucentis* study. "I noticed an improvement after the first
injection, and it's kept on getting better," he said. "I had given up
reading, except for short times with a magnifying glass. Now my
eyesight is almost 20/20 and I read and do everything else without a
problem. The difference is like night and day."
"The approval of Lucentis* to treat vision loss from DME is an important
step forward in alleviating the burden of adult vision loss in Canada,"
said Sharon Colle, President and CEO of The Foundation Fighting
Blindness, based in Toronto. "As an organization dedicated to research
and finding a cure for retinal diseases, it's encouraging to see this
very positive development. We hope persons with DME will quickly get
access to Lucentis* through provincial drug plans."
Lucentis* was specifically developed as a treatment for visual
impairment due to its effect on a protein that plays a critical role in
the leakage of blood vessels in the retina of diabetic patients.
Macular edema is a swelling of the macula from leaking of fluid from
blood vessels, resulting in blurred vision.5 In the clinical trial RESTORE, Lucentis* has been shown to
significantly improve vision compared to laser therapy, the current
standard of care.6
About diabetic macular edema
DME is a common complication of diabetic retinopathy, which is caused by
damage to the blood vessels of the retina and is the leading cause of
vision loss in working-aged adults in the developed world.7,8 In people with diabetes, elevated blood sugar levels can lead to
problems with the blood circulatory system. These problems can result
in symptoms in various areas of the body, such as extremities, but also
including the small blood vessels in the retina of the eye. These
vessels then leak, which causes swelling (edema) of the macula, the
centre of the retina responsible for sharp and straight ahead vision.9 Therefore, DME can lead to significant visual impairment.
The first symptoms of DME are most often "floaters" or spots in the line
of vision, then blurry vision. DME usually progresses slowly with
worsening symptoms and is a lifelong condition. DME with visual
impairment affects 2.6% of diabetics in Canada.10
Lucentis* (ranibizumab) was specifically designed for use in the eye and
is administered by injection into the eye. It is licensed in more than
30 countries for the treatment of vision impairment due to diabetic
macular edema (DME). Earlier this year, Lucentis* was also approved by
Health Canada for the treatment of visual impairment due to macular
edema secondary to retinal vein occlusion (RVO). Lucentis* is licensed
in more than 85 countries, for wet age-related macular degeneration
(AMD). It was approved by Health Canada in 2007 for the treatment of
wet AMD and is available through the public health plans of all 10
provinces to treat that disease.
Canadian approval of Lucentis* for the treatment of visual impairment
due to diabetic macular edema was based on data from the RESTORE study,
involving 345 patients, in which patients treated with either Lucentis*
alone or in combination with laser gained significantly more letters in
visual acuity at 12 months compared to baseline versus patients
treated with laser alone. The safety profile of Lucentis* was
consistent with the well-established profile in patients with wet
age-related macular degeneration (wet AMD).
Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2010, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. It was named for the seventh time as one of the "50
Best Employers in Canada" for 2011. For further information, please
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can," "commitment," "potentially,"
"ongoing," "will," or similar expressions, or by express or implied
discussions regarding potential approvals to sell Lucentis* in
additional markets or regarding potential future revenues from
Lucentis* You should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Lucentis* to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Lucentis* will be approved for sale in
any additional markets. Nor can there be any guarantee that Lucentis*
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Lucentis* could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; competition in general;
government, industry and general public pricing pressures; the
company's ability to obtain or maintain patent or other proprietary
intellectual property protection; the impact that the foregoing factors
could have on the values attributed to the Novartis Group's assets and
liabilities as recorded in the Group's consolidated balance sheet, and
other risks and factors referred to in Novartis AG's current Form 20-F
on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
*Lucentis is a registered trademark of Genentech, Inc., used with
permission by Novartis Pharmaceuticals Canada Inc.
1Canadian Diabetes Association, "Diabetes: Canada at the Tipping Point,"
2 Hariprasad SM et al. Vision-related quality of life in patients with
diabetic macular oedema. Br J Ophthalmol. 2008:92. 89-92 and Davidov E
et al, Diabetic retinopathy and health-related quality of life. Graefs
Arch Clin Exp Ophthalmol, 2009:247:267-272
3,5,7,9 National Eye Institute at www.nei.nih.gov/health/diabetic/retinopathy.asp
4,10 Data on file, Novartis Pharmaceuticals Canada Inc.
6 Data on file, Novartis Pharma AG, Basel, Switzerland
8 Chou TH et al, Relationship of diabetic macular oedema with
glycosylated haemoglobin. Eye. 2009:23:1360-1363.
SOURCE NOVARTIS PHARMACEUTICALS CANADA INC.
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