BUSINESS WIRE
HUENENBERG, Switzerland--(BUSINESS WIRE)--Alcon, Inc. (NYSE:ACL) announced today that the European Medicines
Agency (EMEA) has approved Alcon’s fixed combination eye drop, AZARGA®
(brinzolamide 10mg/ml+timolol 5mg/ml) ophthalmic suspension, for
treatment of elevated intraocular pressure (IOP) associated with
open-angle glaucoma or ocular hypertension in adult patients for whom
monotherapy provides insufficient IOP reduction.
Two clinical studies showed AZARGA® ophthalmic suspension to
be more comfortable and better tolerated by patients than COSOPT*. In a
patient preference study comparing AZARGA® and COSOPT*, 79
percent of the glaucoma patients who expressed a preference preferred
AZARGA®. Many physicians believe that more comfortable
medication may enhance adherence to dosing regimens for patients with
glaucoma, which is critical to protecting them against potential vision
loss.
Clinical trials supporting the approval also showed the active
ingredients in AZARGA® suspension to be more effective when
delivered in combination than either of them individually. AZARGA®
demonstrated superior IOP-lowering efficacy at every time point measured
in the study versus the individual components alone, while demonstrating
a similar safety profile. In addition, a head to head study showed that
AZARGA® provides IOP lowering efficacy that is similar to
COSOPT*.
“This new product is a direct result of our commitment to offering more
treatment options to patients affected by glaucoma," said Sabri Markabi,
M.D., Alcon's senior vice president of research and development and
chief medical officer. “It is important to have an effective treatment
that is both comfortable and convenient for patients with a chronic
disease such as glaucoma.”
AZARGA® ophthalmic suspension will be available in Europe
beginning in early 2009.
About AZARGA® Ophthalmic Suspension
AZARGA® ophthalmic suspension is indicated for the decrease
of intraocular pressure (IOP) in adult patients with open-angle glaucoma
or ocular hypertension for whom monotherapy provides insufficient IOP
reduction. AZARGA® is a formulation that includes both
brinzolamide and timolol. This therapy is contraindicated in patients
with hypersensitivity to the active ingredients in this product. For
complete product information, see product insert.
About Glaucoma
Glaucoma, a group of diseases that can damage the eye’s optic nerve, is
the second leading cause of blindness worldwide. The onset of glaucoma
occurs with no symptoms, but if it remains untreated, gradual loss of
peripheral vision may ensue. When diagnosed early, glaucoma can be
treated with medication, laser trabeculoplasty, conventional surgery or
a combination of therapeutic options. Remaining vision may be preserved
through treatment, but there is currently no cure for glaucoma and lost
vision cannot be restored. Compliance or adherence to these treatments
is essential to retain vision, but for many reasons adherence is a
problem for patients with glaucoma. Some of these reasons include a lack
of symptoms, drug discomfort, multiple drugs prescriptions and
complicated dosing regimens.
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of
approximately $5.6 billion in 2007. Alcon, which has been dedicated to
the ophthalmic industry for 60 years, researches, develops, manufactures
and markets pharmaceuticals, surgical equipment and devices, contact
lens care solutions and other vision care products that treat diseases,
disorders and other conditions of the eye. Alcon's majority shareholder
is Nestle, S.A., the world's largest food company. For more information
on Alcon Inc., visit the company’s Web site at www.alcon.com.
* COSOPT is a registered trademark of Merck & Co., Inc.
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