Alcon announces FDA approval of Simbrinza(TM) Suspension, a new beta blocker-free, fixed-combination therapy for glaucoma patients
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Novartis International AG /
Alcon announces FDA approval of Simbrinza(TM) Suspension, a new beta
blocker-free, fixed-combination therapy for glaucoma patients
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The issuer is solely responsible for the content of this announcement.
* Simbrinza offers a wide range of treatment possibilities due to its strong
efficacy, providing sustained control and a 21%-35% reduction in intraocular
pressure[1],[2],[3]
* Combines Brinzolamide 1.0% and Brimonidine Tartrate 0.2% into one multi-dose
bottle[1],[4]
* Alcon provides a broad spectrum of pharmaceutical and surgical glaucoma
treatment solutions to address patient needs at all stages of the disease
Basel, April 19, 2013 - Alcon, the global leader in eye care and a division of
Novartis, announces US FDA approval for Simbrinza(TM) Suspension, indicated for
the reduction of elevated intraocular pressure (IOP) in patients with primary
open-angle glaucoma or ocular hypertension.[4] Elevated IOP is the only
modifiable risk factor for glaucoma. Glaucoma is a group of eye diseases that
lead to progressive damage of the optic nerve[5] and can result in gradual,
irreversible loss of vision, and eventually blindness, if left untreated.[6]
Glaucoma affects more than 2.2 million Americans[7] and is the second-leading
cause of preventable blindness worldwide.[8]
Simbrinza is a fixed-dose combination medication that offers a wide range of
treatment possibilities due to its strong efficacy and ability to decrease
elevated IOP by 21- 35%.[1],[2],[3] In addition, it is the only available,
fixed-dose combination therapy for glaucoma in the US without a beta
blocker.[1],[2]
"Alcon is the global leader in providing both pharmaceutical and surgical
options for patients living with glaucoma," said Robert Warner, Area President,
US and Canada for Alcon. "The introduction of Simbrinza further expands our
ability to provide effective treatments for patients with elevated IOP. Given
its excellent efficacy, established safety profile, and the fact that it is the
only available, fixed-dose combination without a beta blocker approved in the
US, Simbrinza has the potential to re-shape the treatment paradigm for
glaucoma."
The new ophthalmic suspension is a fixed-dose combination of a carbonic
anhydrase inhibitor (Brinzolamide 1.0%) and an alpha 2 adrenergic receptor
agonist (Brimonidine Tartrate 0.2%).[1],[4] It combines the two drugs into one
multi-dose bottle, helping to reduce the medication burden for glaucoma
patients.[9] Patients are to administer one drop of Simbrinza into the affected
eye(s), three times per day.
"Simbrinza represents an important new option for treating glaucoma patients
with elevated IOP," said Gregory Katz, MD, Glaucoma Service, St. Joseph Mercy
Medical Center, Ann Arbor, Michigan. "Glaucoma must be treated over the course
of one's life, and elevated eye pressure must be managed every day. It's
exciting to now have a product available that combines two effective compounds
into one multi-dose combination, offering sustained control."
The FDA approval of Simbrinza is based on data from two pivotal Phase III
clinical trials with approximately 1,300 patients.[1],[2] The studies evaluated
the safety and efficacy of a fixed-dose combination of Brinzolamide 1.0% and
Brimonidine 0.2%, administered three times daily, compared to separate three-
times-per-day dosing of one or the other component.[1],[2] Both studies met
their primary endpoint and demonstrated that Simbrinza is statistically superior
compared to either component regarding mean IOP at Month 3 for all time points.
[1],[2] In both studies, Simbrinza achieved a 5mm Hg to 9mm Hg reduction from
baseline to Month 3. Patients' mean IOP at baseline was 22mm Hg to 36mm Hg.
[1],[2],[3]
In the two, three-month clinical trials, the most frequently reported adverse
reactions in patients treated with Simbrinza (occurring in approximately 3-5% of
patients in descending order of incidence) were blurred vision, eye irritation,
dysgeusia (bad taste), dry mouth and eye allergy. Treatment discontinuation
mainly due to adverse reaction was reported in 11% of Simbrinza patients.[4] The
safety profile of the combination agent (Simbrinza) is comparable to each of the
individual components. [1],[2] Additionally, there were no significant
cardiovascular or pulmonary events found with Simbrinza in either clinical study
conducted. [1],[3]
About Glaucoma
More than 67 million people worldwide have glaucoma, which is the second-leading
cause of preventable blindness[8] and a disease that many know little about.[10]
Glaucoma is a group of eye diseases that lead to progressive damage of the optic
nerve.[5] Because the optic nerve transmits information from the eye to the
brain,[11] glaucoma can result in a gradual, irreversible loss of vision and
eventually blindness, if left untreated.[6] Elevated eye pressure is often
present and is considered a risk factor for glaucoma.[11] However, in rare
cases, even patients with a normal range of IOP can develop the disease.[6] The
exact cause of glaucoma is unknown.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," or similar expressions, or by express or
implied discussions regarding potential additional marketing approvals for
Simbrinzaor regarding potential future revenues from Simbrinza. 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 Simbrinzato be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Simbrinzawill be submitted or approved for sale in any
additional markets, or at any particular time. Nor can there be any guarantee
that Simbrinza will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Simbrinza 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.
About Alcon
Alcon, the global leader in eye care, provides innovative products that enhance
quality of life by helping people worldwide see better. The three Alcon
businesses - Surgical, Pharmaceutical and Vision Care - offer the widest
spectrum of eye care products in the world. Alcon is the second largest division
of the Novartis Group with pro-forma sales of USD 10.2 billion in 2012.
Headquartered in Fort Worth, Texas, U.S.A., Alcon has more than 24,000 employees
worldwide, operations in 75 countries and products available in 180 markets. For
more information, visit www.alcon.com.
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 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 128,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
1. Katz G, DuBiner H, Samples J, et al. Three-month randomized trial of fixed-
combination Brinzolamide 1%/Brimonidine 0.2% versus Brinzolamide 1% versus
Brimonidine 0.2% in patients with open-angle glaucoma or ocular
hypertension. Glaucoma.
2. Nguyen QH, McMenemy MG, Realini T. Phase 3 randomized 3-month trial with an
ongoing 3-month safety extension of fixed-combination Brinzolamide
1%/Brimonidine 0.2%. J Ocul Pharmacol Ther.
3. Data on file, 2013
4. Simbrinza Suspension Package Insert
5. American Optometric Association. Glaucoma http://www.aoa.org/Glaucoma.xml
6. National Eye Institute. Facts about Glaucoma
http://www.nei.nih.gov/health/glaucoma/glaucoma_facts.asp
7. Glaucoma Research Foundation, Glaucoma Facts and Stats
http://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php
8. Lighthouse International, Prevalence of Vision Impairment
http://www.lighthouse.org/research/statistics-on-vision-
impairment/prevalence-of-vision-impairment/
9. Curr Hypertens Rep. 2007 Jun;9(3):184-9 Compliance and Fixed-dose
Combination Therapy http://www.ncbi.nlm.nih.gov/pubmed/17519122
10. Burr JM, Mowatt G, Hernández R, Siddiqui MA, Cook J, Lourenco T, et al. The
clinical effectiveness and cost-effectiveness of screening for open angle
glaucoma: a systematic review and economic evaluation. Health Technology
11. Glaucoma Research Foundation. What is Glaucoma, How Glaucoma Affects the
Optic Nerve http://www.glaucoma.org/glaucoma/the-optic-nerve-questions-and-
answers-from-dr-bradley-schuster.php
# # #
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Datum: 19.04.2013 - 22:16 Uhr
Sprache: Deutsch
News-ID 251013
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contact information:
Town:
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