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news.Alcon, an eye care company, has announced that the European Medicines Agency has approved its fixed combination eye drop, Azarga ophthalmic suspension, for treatment of elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction. Azarga ophthalmic suspension will be available in Europe beginning in early 2009.
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According to the company two clinical studies have shown Azarga ophthalmic suspension to be more comfortable and better tolerated by patients than Cosopt. In a patient preference study comparing Azarga and Cosopt, 79% of the glaucoma patients who expressed a preference preferred Azarga.
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 intraocular pressure (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.
Sabri Markabi, Alcon’s senior vice president of R&D and chief medical officer, said: This new product is a direct result of our commitment to offering more treatment options to patients affected by glaucoma. It is important to have an effective treatment that is both comfortable and convenient for patients with a chronic disease such as glaucoma.