Alcon Announces AZARGA(R) Ophthalmic Suspension Approved For Treatment Of Patients With Glaucoma Or Ocular Hypertension In The European Union

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Dec 2008 - 1:00 PST

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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 http://www.alcon.com.

* COSOPT is a registered trademark of Merck & Co., Inc.

Caution Concerning Forward-Looking 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 expressed or implied by our forward-looking statements. These statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules an regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Alcon, Inc.