Novartis International AG: Alcon receives positive NICE recommendation for
Jetrea® to treat eligible patients with vitreomacular traction, including
Novartis International AG / Alcon receives positive NICE recommendation for
Jetrea® to treat eligible patients with vitreomacular traction, including
macular hole . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.
*One-time single eye injection of Jetrea^® recognized as clinically and
cost-effective treatment for eligible patients with vitreomacular
traction, including macular hole
*Jetrea^® is the first and only approved pharmacological treatment in the
UK for this sight-threatening condition
*Vitreomacular traction with macular hole is an age-related eye condition
that can cause loss of vision and impaired quality of life
Basel, October 23, 2013 - Alcon, the global leader in eye care, and second
largest division of Novartis, is pleased that the National Institute for
Health and Care Excellence (NICE) has recommended Jetrea^® (ocriplasmin) as a
clinically and cost-effective treatment option for eligible patients suffering
from vitreomacular traction including when associated with macular hole. With
this final NICE guidance, Jetrea^® is now recommended for use within the
National Health Service (NHS) in England and Wales as the first and only
pharmacological treatment for this sight-threatening eye condition.
"We are very pleased by the NICE decision, as Jetrea^® represents a
breakthrough treatment option for patients in the UK, which is now recommended
for use in the NHS," said Stuart Raetzman, Area President Europe, Middle East
and Africa, Alcon. "At Alcon, we aim to deliver positive patient outcomes
through innovative medicines and medical devices. We work closely with doctors
and health care providers to shape the future of eye care and offer solutions
to address unmet patient needs."
Vitreomacular traction and macular hole is an age-related, sight-threatening
condition that may lead to visual distortion and central
blindness.,,,,Up to now, the clinical approach for treating
vitreomacular traction has been 'watchful waiting,' meaning patients undergo a
period of observation before they become eligible for eye surgery due to
worsening of their condition. Due to the potential risks and complications,
surgery is mostly reserved for patients who are heavily impacted by the
symptoms of vitreomacular traction.
"People affected by vitreomacular traction can suffer vision changes that have
a significant impact on their lives, making it difficult to do everyday
activities like reading, watching TV and driving." said Tim Jackson, Retinal
Surgeon at King's College Hospital. "Until now, eye doctors have only had
surgical options to treat this disease, once it progressed to a severe stage.
This new treatment is a welcome advance, meaning some patients can now avoid
surgery, and others who might not be suitable for surgery can now be treated."
Jetrea^® was approved in March 2013 by the EU Commission for the treatment of
vitreomacular traction, in adults, including when associated with macular hole
of less than or equal to 400 microns. In the UK, NICE recommended Jetrea^®
to treat patients suffering from vitreomacular traction, including macular
hole of less than or equal to 400 microns when an epiretinal membrane is
absent, or adults with vitreomacular traction and severe symptoms, when an
epiretinal membrane and macular hole are both absent.
It is delivered as a single, once-only injection into the eye, and studies
showed that within 28 days, in approximately one out of four patients,
Jetrea^® successfully resolved vitreomacular adhesion. In addition, over 40%
of patients treated with Jetrea^® achieved closure of a macular hole by day
Alcon acquired the rights to commercialize Jetrea^® outside the US from the
Belgian biopharmaceutical company, ThromboGenics, which retains the rights to
commercialize the drug in the US. In October 2012, Jetrea^® was licensed in
the US for the treatment of patients with symptomatic vitreomacular adhesion.
About vitreomacular traction, including macular hole
As people get older, the vitreous (jelly-like material inside the eye that
helps maintain the round shape) detaches naturally from the retina (the
light-sensitive layer of tissue located at the back of the eyeball). However,
in some cases, the vitreous remains attached to areas of the retina,
particularly at the macula (the area of the retina responsible for central
vision needed for everyday tasks such as driving, reading and recognizing
faces). This is known as vitreomacular adhesion. If left unresolved, these
areas of vitreomacular adhesion can exert a 'pulling force' on the macula, a
condition known as vitreomacular traction. Vitreomacular traction may
eventually lead to the formation of a hole in the macula and is often
responsible for progressive, sight-threatening symptoms and irreversible
vision loss. Risk factors for vitreomacular traction and macular hole are
undetermined, meaning anyone can be affected as they age.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "positive recommendation," "recommended,"
"aim," "shape the future," "expect," "potential," or similar expressions, or
by express or implied discussions regarding potential additional marketing
approvals or recommendations for Jetrea or regarding potential future revenues
from Jetrea. 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 Jetrea to be materially different
from any future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that Jetrea will be approved for
sale in any additional markets, or at any particular time. Nor can there be
any guarantee that Jetrea will achieve any particular levels of reimbursement
or revenue in the future. In particular, management's expectations regarding
Jetrea 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; government, industry and general public
pricing pressures; competition in general; unexpected manufacturing issues;
the company's ability to obtain or maintain patent or other proprietary
intellectual property protection; and 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. Jetrea is a trademark of
ThromboGenics NV, licensed to Alcon.
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 and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group
amounted to approximately USD 9.3 billion (USD 9.1 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 133,000 full-time-equivalent associates and operate in more than
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Novartis is on Twitter. Sign up to follow @Novartis at
 Carpineto P, Di Antonio L, Aharrh-Gnama A, et al. Diagnosing and Treating
Vitreomacular Adhesion. Retina 2011 69-73.
 Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome.
Am J Ophthalmol. 1995;119(1):55-61.
 Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of
Opthalmalic and Vision Research. 2012;7(2):148-161.
 Jaffe NS. Vitreous traction at the posterior pole of the fundus due to
alterations in the vitreous posterior. Trans Am Acad Ophthalmol
 Johnson MW. Perifoveal vitreous detachment and its macular complications.
Trans Am Ophthalmol Soc. 2005;103:537-567.
 Jetrea^® Summary of Product Characteristics. ThromboGenics NV. Belgium;
 NICE. Ocriplasmin for treating vitreomacular traction. NICE technology
appraisal guidance 297. October 2013.
 Stalmans P, Benz MS, Gandorfer A, et al. Enzymatic vitreolysis with
ocriplasmin for vitreomacular traction and macular holes. N Engl J Med
 Steidl S,Hartnett ME. Clinical Pathways In Vitreoretinal Disease
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