Full Press Release Details
Ophthalmic Suspension Approved for Treatment of Patients with Glaucoma or
Ocular Hypertension in the European Union
Huenenberg, Switzerland - December 2,
2008 - 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
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.
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
IOP lowering efficacy that is similar to COSOPT*.
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
ophthalmic suspension will be available in Europe beginning in early
Ophthalmic Suspension
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
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.
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.
is a registered trademark of Merck & Co., Inc.
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Statements. This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. These statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or achievements to be
materially different from any future results, performances or achievements
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understanding that our actual future results may be materially different from
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