31.10.2007 13:00:00
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Allergan, Inc. Receives FDA Approval for COMBIGAN(TM) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
Allergan, Inc. (NYSE:AGN) today announced that the U.S. Food and Drug
Administration has approved COMBIGAN™
(brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an
alpha adrenergic receptor agonist with a beta adrenergic receptor
inhibitor, for the reduction of elevated intraocular pressure (IOP) in
patients with glaucoma or ocular hypertension who require adjunctive or
replacement therapy due to inadequately controlled IOP. COMBIGAN™
is the newest addition to Allergan’s
comprehensive glaucoma portfolio, which also includes LUMIGAN®
(bimatoprost ophthalmic solution) 0.03% and ALPHAGAN®
P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%.
"COMBIGAN™
ophthalmic solution is a medication that provides well documented safety
and efficacy for patients with inadequately controlled IOP,”
said Scott Whitcup, M.D., Allergan’s
Executive Vice President, Research and Development. "The
development of COMBIGAN™,
which has included five key clinical studies, underscores Allergan’s
commitment to provide new treatment options for patients with glaucoma.”
COMBIGAN™ is a
prescription eye drop that works in two ways to reduce elevated IOP and
will be available to physicians in the fourth quarter of 2007. Elevated
IOP is a leading risk factor for glaucoma, and the only risk factor that
can currently be treated.
"There is no cure for glaucoma; however,
lowering elevated IOP can slow the progression of the disease and help
prevent further vision loss,” said E. Randy
Craven, M.D., Director of Glaucoma Consultants of Colorado and Associate
Clinical Professor of Ophthalmology, University of Colorado School of
Medicine. "Many patients require more than
one medication to meet their target IOP. With COMBIGAN™,
it is exciting to be able to offer patients two strong agents in one
bottle.”
In the 12-month pivotal trials, COMBIGAN™
significantly reduced mean IOP up to 7.6 mm Hg from baseline and was
well tolerated.1 Clinical studies found that
COMBIGAN™ ophthalmic
solution provided an additional IOP lowering versus either brimonidine
or timolol, the two agents included in the formulation of COMBIGAN™,
used alone. COMBIGAN™ administered
twice a day provided an additional 1 to 3 mm Hg decrease in IOP over
brimonidine treatment three times a day and an additional 1 to 2 mm Hg
decrease over timolol treatment twice a day. The IOP-lowering of COMBIGAN™
ophthalmic solution dosed twice a day was slightly less than that seen
with the concomitant administration of timolol maleate ophthalmic
solution 0.5% dosed twice a day and brimonidine tartrate ophthalmic
solution 0.2% dosed three times per day.2 About Glaucoma
Glaucoma, a group of eye diseases characterized by damage to the optic
nerve, is a leading cause of preventable blindness in the United States.3
It is estimated that more than three million Americans have glaucoma,
but only half of those know they have it.4 The
total number of glaucoma cases worldwide is estimated to be 65 million.4
One of the risk factors of glaucoma is elevated IOP, or pressure inside
the eye. A healthy eye produces fluids, called aqueous humor, at the
same rate fluids are drained. If the aqueous humor is not removed
rapidly enough or too rapidly, pressure builds up in the eye, which can
result in glaucoma. This high pressure distorts the shape and damages
the optic nerve. Maintaining healthy IOP levels may slow the progression
of the disease and help prevent loss of vision.
Important Safety Information: Contraindications: COMBIGAN™
ophthalmic solution is contraindicated in patients with bronchial
asthma, a history of bronchial asthma, severe chronic obstructive
pulmonary disease; in patients with sinus bradycardia, second or third
degree atrioventricular block, overt cardiac failure, cardiogenic shock;
and in patients with hypersensitivity to any component of this product.
Warnings and Precautions: Severe respiratory reactions including
death due to bronchospasm in patients with asthma have been reported
following systemic or ophthalmic administration of timolol maleate.
Sympathetic stimulation may be essential in individuals with diminished
myocardial contractility, and its inhibition by beta-adrenergic receptor
blockade may precipitate more severe cardiac failure. In patients
without a history of cardiac failure, continued depression of the
myocardium with beta-blocking agents over a period of time can, in some
cases, lead to cardiac failure. Patients with chronic obstructive
pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or
moderate severity, bronchospastic disease, or a history of
bronchospastic disease should, in general, not receive beta-blocking
agents, including COMBIGAN™.
COMBIGAN™ may
potentiate syndromes associated with vascular insufficiency. While
taking beta-blockers, patients may be more reactive to allergens.
Beta-adrenergic blockade has been reported to potentiate muscle weakness
consistent with certain myasthenic symptoms. Beta-adrenergic receptor
blocking agents may mask hypoglycemic symptoms in patients with diabetes
mellitus. Beta-adrenergic blocking agents may mask certain clinical
signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of
developing thyrotoxicosis should be managed carefully to avoid abrupt
withdrawal of beta-adrenergic blocking agents that might precipitate a
thyroid storm.
Adverse reactions: The most common adverse reactions occurring in
approximately 5 to 15 percent of patients included allergic
conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye
pruritus, and ocular burning and stinging.
About Allergan, Inc.
With more than 55 years of experience providing high-quality,
science-based products, Allergan, Inc., with headquarters in Irvine,
California, discovers, develops and commercializes products in the
ophthalmology, neurosciences, medical dermatology, medical aesthetics,
obesity intervention, urologics and other specialty markets that deliver
value to its customers, satisfy unmet medical needs, and improve
patients' lives.
Forward-Looking Statements
This press release contains "forward-looking statements", including the
statements by Dr. Whitcup and Dr. Craven and other statements regarding
research and development outcomes, efficacy, market and product
potential and other statements regarding COMBIGAN™.
These statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
Allergan's expectations and projections. Risks and uncertainties
include, among other things, general industry and pharmaceutical market
conditions; technological advances and patents attained by competitors;
challenges inherent in the research and development and regulatory
processes; challenges related to new product marketing, such as the
unpredictability of market acceptance for new pharmaceutical and
biologic products and/or the acceptance of new indications for such
products; inconsistency of treatment results among patients; potential
difficulties in manufacturing a new product formulation; and
governmental laws and regulations affecting domestic and foreign
operations. Additional information concerning these and other risk
factors can be found in press releases issued by Allergan, as well as
Allergan’s public periodic filings with the
Securities and Exchange Commission, including the discussion under the
heading "Risk Factors”
in Allergan’s 2006 Form 10-K and Allergan’s
Form 10-Q for the quarter ended June 29, 2007. Copies of Allergan’s
press releases and additional information about Allergan is available on
the World Wide Web at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
1-714-246-4636.
1 Sherwood MB, Craven ER, Chou C, et al.
Twice-daily 0.2% brimonidine-0.5%/timolol fixed-combination therapy vs
monotherapy with timolol or brimonidine in patients with glaucoma and
ocular hypertension: a 12-month randomized trial. Arch Ophthalmol.
2006; 124(9): 1230-1238.
2 COMBIGAN™
prescribing information.
3 Eyecare America; The Foundation of the
American Academy of Ophthalmology. "Facts About Blindness and Eye
Health." Available at: http://www.eyecareamerica.org/eyecare/news/press/upload/
Facts-About-Blindness.pdf. Accessed October 30, 2007.
4 Glaucoma Research Foundation. "Glaucoma
Facts and Stats” Available at: http://www.glaucoma.org/learn/glaucoma_facts.html.
Accessed October 16, 2007.
® and ™
Marks owned by Allergan, Inc.
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