Lucentis (ranibizumab) approved by Health Canada to treat vision

Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
Canada H9S 1A9
www.novartis.ca
MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE
Pr
Lucentis® (ranibizumab) approved by Health Canada to treat vision
loss resulting from choroidal neovascularization in pathologic myopia
(mCNV)1


Fourth indication for injection treatment that can stabilize and improve vision1
mCNV a leading cause of visual impairment among those 20–50 years of age9
Since its launch in Canada in 2007, Lucentis® has treated more than 100,000 eyes
across all approved indications3
Dorval, Quebec, October 8, 2014 – Novartis Pharmaceuticals Canada Inc. announced
today that Lucentis® (ranibizumab), the treatment for several major causes of vision loss,
has been approved by Health Canada for the treatment of visual impairment due to
choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).1
Myopic CNV (mCNV) develops in 5–10% of patients with pathologic myopia,4 which is a
leading cause of blindness in many developed countries5 and second only to wet agerelated macular degeneration in causing CNV.8 Abnormal blood vessels form beneath
the retina of the eye and can rupture, leaking blood and fluid into the retina, causing
vision loss.6 It is estimated that every day, almost five Canadians start experiencing
vision loss from mCNV.7 In patients with untreated mCNV the long-term prognosis is
poor, with approximately 90 per cent developing severe vision loss after five years.10 The
condition is more than twice as prevalent in Asian populations as European populations.6
“The thought of losing your vision can be devastating and the patients I see with this
condition are generally young, healthy adults who are working and have a bright future
before them. The approval of Lucentis® for mCNV equips us as physicians because until
now we were only able to slow down vision loss in these patients,” said Dr. David Wong,
Ophthalmologist-in-Chief at St. Michael’s Hospital in Toronto. “Improving vision in these
patients allows them to continue working and get on with their busy lives.”
Lucentis® is an inhibitor of vascular endothelial growth factor (VEGF), one of the key
elements in the formation of new and abnormal blood vessels beneath the retina which
cause vision loss associated with both mCNV6 and the more prevalent condition of wet
age-related macular degeneration (AMD).1,11 Treatment of vision loss from mCNV with
Lucentis® starts with a single injection, with further injections as needed based on
disease activity, which is monitored monthly for the first two months then at least
quarterly for up to one year. After the first year, frequency of monitoring is at the
discretion of the treating physician.1
When 67-year-old Harry Tiefenbach of Toronto started losing vision from mCNV, he
knew it would have devastating effects. “My vision started blurring all the time and was
distorted. I’m an artist and painting is my life. I prepared for the worst but did not know
how I would pick up the pieces after losing my vision,” he said. “When my doctor first told
me about Lucentis®, I had hope. Soon after my first injection, my vision started improving.
Today, I’m still painting and doing all the things I want to do. It’s made a big difference in
my life and for my family.”
Page 1 of 3
The Phase III study on which the approval of the new indication was based, showed that
treatment with Lucentis® was superior to the previous standard of care, Visudyne®
(verteporfin PDT).1 Lucentis® improved mean visual acuity by about 14 letters (on an eye
chart) after one year. This result was achieved with a median of two injections over the
12 months. Over 60 per cent of patients in the trial did not need any further injections
after six months. Previous treatments for mCNV aimed to stabilize vision but generally
did not improve visual acuity.1,8
About Lucentis®
Lucentis® (ranibizumab) was specifically designed for use in the eye and is administered
by injection into the eye. It is licensed in more than 40 countries for the treatment of
visual impairment due to mCNV.3 It was first approved by Health Canada in 2007 for the
treatment of wet age-related macular degeneration (AMD) and is available through the
public health plans of all 10 provinces to treat that disease. It is also approved in Canada
for the treatment of visual impairment due to diabetic macular edema (DME) and visual
impairment due to macular edema secondary to retinal vein occlusion (RVO).1
About 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 wellbeing of all Canadians. In 2013, the company invested close to $100 million in research
and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than
600 people in Canada. For further information, please consult www.novartis.ca.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of
patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified
portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines, over-the-counter and animal health products.
Novartis is the only global company with leading positions in these areas. In 2013, the
Group achieved net sales of USD 57.9 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 135,000 fulltime-equivalent associates and sell products in more than 150 countries around the
world. For more information, please visit www.novartis.com.
###
®
Lucentis is a registered trademark of Genentech Inc., used with permission by Novartis
Pharmaceuticals Canada Inc.
®
Visudyne is a registered trademark of Novartis Pharmaceuticals Canada Inc.
Novartis Media Relations
Julie Schneiderman
Novartis Pharmaceuticals Canada Inc.
+1 514 633-7873
camlph.communications@novartis.com
References:
1. Lucentis® Product Monograph. Novartis Pharmaceuticals Canada Inc., May 28,
2014.
2. Silva R. Myopic maculopathy: a review. Ophthalmologica 2012; 228(4):197-213.
3. Data on file. Novartis Pharmaceuticals Canada Inc.
4. Nguyen JK, Jeffrey SH. Chapter 23:Choroidal neovascularization secondary to
inflammation, infection, and myopia. In: Nguyen QD, Rodrigues EB, Farah ME,
Mieler WF, eds. Retinal Pharmacotherapy. USA: Saunders Elsevier; 2010.
Page 2 of 3
5. Ohno-Matsui K, Yoshida T, Futagami S et al. Patchy atrophy and lacquer cracks
predispose to the development of choroidal neovascularisation in pathological
myopia. Br J Ophthalmol 2003; 87: 570-3.
6. Wong TY, Ferreira A, Hughes R et al. Epidemiology and disease burden of
pathologic myopia and myopic choroidal neovascularization: an evidence-based
systematic review. Am J Ophthalmol 2014; 157(1): 9-25.e12.
7. Canadian annual incidence of 0.0061% from Pickering M, Luciani L, Zaour N et
al. Prevalence, incidence and characteristics of patients with choroidal
neovascularization secondary to pathologic myopia in a representative Canadian
cohort. Association for Research in Vision and Ophthalmology (abstract) 2014
applied to Canadian 2013 adult (20+) population of 27,305,200 = 1638.3 new
cases per year in Canada. Population data from Statistics Canada, Population by
sex and age group 2013, CANSIM Table 051-0001, accessed at:
http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo10a-eng.htm
8. Neelam K, Cheung CMG, Ohno-Matsui K et al. Choroidal neovascularization in
pathological myopia. Prog Retin Eye Res 2012; 31(5): 495-525.
9. Mones JM, et al. Intravitreal ranibizumab for choroidal neovascularization
secondary to pathologic myopia: 12-month results. Eye. 2009;23:1275-1281.
10. Yoshida T, Ohno-Matsui K, Yasuzumi K et al. Myopic Choroidal
Neovascularization: A 10-year Follow-up, Ophthalmology 2003;110:1297-1305.
11. CNIB, Treatments for Wet AMD, accessed Aug. 13, 2014 at:
http://www.cnib.ca/en/your-eyes/eye-conditions/amd/treatment/treatmentwet/Pages/default.aspx
Page 3 of 3