Bli medlem
Bli medlem

Du är här


Novartis International AG: Alcon receives FDA approval of new multifocal intraocular lens to treat cataract patients in the United States

Novartis International AG / Alcon receives FDA approval of new multifocal
intraocular lens to treat cataractpatients in the United States . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* US Food and Drug Administration (FDA) grants approval of the AcrySof®IQ
ReSTOR®+2.5 Diopter (D) Intraocular Lens (IOL) for sale in the US

* Expands Alcon's IOL portfolio for the correction of near, intermediate and
distance vision in patients undergoing cataract surgery, with increased
independence from glasses

* More than three million cataract surgeries are performed each year in the

Basel, Switzerland, April 16, 2015
Alcon, the global leader in eye care and a division of Novartis, has received
approval from the US Food and Drug Administration (FDA) for its AcrySof®IQ
ReSTOR®+2.5 Diopter (D) Intraocular Lens (IOL) for patients undergoing
cataract eye surgery who choose to address their near, intermediate, and
distance vision needs at the same time. The AcrySof IQ ReSTOR +2.5 D IOL is
the latest addition to Alcon's broad portfolio of intraocular lenses for
cataract patients and provides an additional option to meet the visual needs
of each individual patient.

"We are pleased by the FDA's decision to approve our AcrySof IQ ReSTOR +2.5 D
IOL," said Sabri Markabi, Senior Vice President, Research and Development for
Alcon. "This technology complements our existing AcrySof IQ ReSTOR +3.0 D IOL
in the marketplace, providing more presbyopia-correcting options for
ophthalmic surgeons and the patients they serve."

More than three million cataract surgeries are performed each year in the
United States.[1]
Without presbyopia-correcting IOLs, most patients undergoing cataract surgery
experience poor near vision requiring vision correction such as reading
glasses or contact lenses. The AcrySof IQ ReSTOR +2.5 D IOL is indicated for
adult patients with and without presbyopia undergoing cataract surgery who
desire near, intermediate and distance vision with increased spectacle

"With the addition of AcrySof IQ ReSTOR +2.5 D IOL, surgeons now have a
broader range of treatment options to meet the vision needs of cataract
patients seeking presbyopia correction, based on various lifestyle
requirements," said Lisa Cibik, M.D. FACS, Director of Cataract Services at
Associates in Ophthalmology of Pittsburgh, PA. "The ReSTOR +2.5 D IOL helps
surgeons meet the needs of cataract patients with active lifestyles."

The Centers for Medicare and Medicaid Services (CMS) added the AcrySof IQ
ReSTOR +2.5 D IOL to the list of CMS recognized presbyopia-correcting IOLs,
confirming that AcrySof IQ ReSTOR +2.5 D IOLs will be eligible for
reimbursement as both a Medicare-covered service (treatment of cataract) and
as a non-covered service (presbyopia correction).[2] Alcon will commercialize
the AcrySof IQ ReSTOR +2.5 D IOL in the United States in the near future. The
product is already commercially available in the European Union, Australia,
Canada, Japan and countries in Central and South America. Close to 27,000
AcrySof IQ ReSTOR +2.5 D IOLs have already been implanted in the countries
where they are commercially available.

About Cataracts

A cataract is a clouding of the natural lens of the eye that affects vision.
As a cataract develops, the eye's lens gradually becomes hard and cloudy
which scatters light rays and allows less light to pass through, which makes
it more difficult to see. The vast majority of cataracts happen as a result
of normal aging but radiation exposure, taking steroids, diabetes, and eye
trauma can accelerate the development of cataracts. Additionally, cataracts
can be hereditary and congenital and can present shortly after birth.[2]
Cataracts are the most common age-related eye condition and the leading cause
of preventable blindness in adults 55 and older.[3]Twenty million people in
the US age 40 and older have cataracts.[4] Cataracts are treated by
surgically removing the eye's cloudy natural lens and replacing it with an
intraocular lens (IOL). More than 98 percent of cataract surgeries are
considered successful and patients can usually return to their normal
routines within 24 hours.[5]

About Presbyopia

Presbyopia is an eye condition that occurs as part of natural aging. It
involves the gradual loss of the eye's ability to actively focus on close
objects, such as smart phones, computers, books and menus.[6] The first signs
of presbyopia are eyestrain, difficulty seeing up close in dim light and
problems focusing on small objects and/or fine print. Once a person is in
their 40s, it is likely they will experience presbyopia and will require
vision correction such as reading glasses or multifocal contact lenses.[7]

Important Information About AcrySof ReSTOR IOLs

Careful preoperative evaluation and sound clinical judgment should be used by
the surgeon to decide the risk/benefit ratio before implanting a lens in a
patient with any of the conditions described in the AcrySof ReSTOR physician
labeling. Some patients may experience visual disturbances and/or discomfort
due to multifocality, especially under dim light conditions. As with other
multifocal IOLs, visual symptoms may be significant enough that the patient
will request explant of an AcrySof ReSTOR IOL. Clinical studies with the
AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO) may
significantly affect the vision of patients sooner in its progression than
patients with monofocal IOLs.


The foregoing release contains forward-looking statements that can be
identified by words such as "can," "may," "should," or similar terms, or by
express or implied discussions regarding potential additional marketing
approvals for the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens , or
regarding potential future revenues from the AcrySof IQ ReSTOR +2.5 Diopter
Intraocular Lens . You should not place undue reliance on these statements.
Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those set forth in
the forward-looking statements. There can be no guarantee that the AcrySof IQ
ReSTOR +2.5 Diopter Intraocular Lens will be submitted or approved for sale
in any additional markets, or at any particular time. Nor can there be any
guarantee that the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens will be
commercially successful in the future. In particular, management's
expectations regarding the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens
could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; the company's ability to
obtain or maintain proprietary intellectual property protection; general
economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected manufacturing
issues, and other risks and factors referred to in Novartis AG's current Form
20-F on file with the US Securities and Exchange Commission. 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

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 and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2014, the Group
achieved net sales of USD 58 billion, while R&D throughout the Group amounted
to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). As of December 31, 2014 Novartis Group companies
employed approximately 133,000 full-time-equivalent associates. Novartis
products are available in more than 180 countries around the world. For more
information, please visit

Novartis is on Twitter. Sign up to follow @Novartis


[1] Riley AF, Grupcheva CN, Malik TY, Craig JP, McGhee CN. The Auckland
Cataract Study: demographic, corneal topographic and ocular biometric
parameters. Clin Experiment Ophthalmol 2001;29:381-6.
[2] NIH, NEI, Facts About Cataracts, September 2009. Available

[3] National Institutes of Health (NIH), National Eye Institute (NEI), Eye
Health Needs of Older Adults Literature Review, 2007. Available

[4] Centers for Disease Control and Prevention (CDC), Common Eye Disorders,
July 2009. Available

[5] Eye Surgery Education Council, Cataract Surgery, accessed August 2013.
Available at:

[6] Mayo Clinic,Presbyopia. [accessed July 1, 2014].

[7] Market Scope,Global Presbyopia-Correcting Surgery Market Report,
April 2012.

# # #

Novartis Media Relations

| Central media line : |
|+41 61 324 2200 |
| Eric Althoff Elizabeth Harness Murphy |
| |
|Novartis Global Media Relations Novartis Alcon Communications |
|+41 61 324 7999 (direct) + 1 817 551 8696 (direct) |
|+41 79 593 4202 (mobile) + 1 585 435 7379 (mobile) |
| |

For Novartis multimedia content, please

For questions about the site or required registration, please

Novartis Investor Relations

| Central phone: +41 61 324 7944 |

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.