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Alcon Receives Approval of Retaane Suspension (Anecortave Acetate Suspension) in Australia
HUNENBERG, SWITZERLAND -- December 13, 2005 -- Alcon, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has approved RetaaneŽ suspension (15mg anecortave acetate suspension) for the treatment of subfoveal choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD) where there is a classic component.
"We are pleased to gain approval of RetaaneŽ suspension in Australia for all lesions with a classic component because we believe RetaaneŽ suspension can provide retinal specialists with a unique new therapy to treat wet AMD. We will continue our efforts to gain approval of RetaaneŽ suspension in other jurisdictions, including the U.S., Europe, Canada, South Africa, New Zealand and Switzerland," said Scott Krueger, PhD, Alcon's vice president, R&D Pharmaceutical Development.
The company also announced that it has executed a Clinical Trial Agreement with the National Eye Institute (NEI) in the U.S., in which Alcon will provide RetaaneŽ suspension for an NEI study of wet AMD. The study will be a multi-center, randomized, prospective clinical trial that will investigate the long-term safety and potential efficacy of RetaaneŽ suspension in patients with all forms of wet AMD who are undergoing intravitreal AVASTIN therapy.
About RetaaneŽ Suspension
RetaaneŽ suspension is an investigational treatment for maintaining vision in patients with wet AMD. The drug is an angiostatic cortisene that inhibits the abnormal growth of blood vessels, a process scientifically known as angiogenesis. Angiostatic cortisenes are derived from the steroid class and engineered to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against angiogenesis.
RetaaneŽ suspension is administered every six months with a blunt-tipped, curved cannula to deliver the drug behind the eye without puncturing the eyeball. This method of delivery avoids the risk of intraocular infection and retinal detachment, the most common side effects associated with injecting therapeutic agents directly into the eye.
SOURCE: Alcon, Inc.
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