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European Advisory Panel Recommends Approval of Age-Related Blindness Treatment Macugen

NEW YORK, Sept. 16 /PRNewswire-FirstCall/ -- Eyetech Pharmaceuticals, Inc. (Nasdaq: EYET - News) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of Macugen® (pegaptanib sodium injection) for the treatment of neovascular (wet) age- related macular degeneration (neovascular AMD). The CHMP recommendation of Macugen serves as a basis for EMEA approval. The European Commission is expected to issue an authorization decision regarding the marketing of Macugen in European Union countries by the end of the year.

Macugen was approved by the U.S. Food and Drug Administration in December 2004 and by Brazilian regulatory authorities in May 2005 for use in the treatment of neovascular AMD. In May 2005, Canadian regulatory authorities approved Macugen for the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration. Macugen is currently available in the U.S. and Canada. Macugen applications have also been filed in twelve additional countries.

Eyetech and Pfizer Inc co-promote Macugen in the United States. Eyetech has granted Pfizer the exclusive rights to commercialize Macugen in countries outside the United States pursuant to a royalty-bearing licensing agreement.

About Macugen
Macugen is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two pathological processes that contribute to the vision loss associated with neovascular AMD.

For full prescribing information about Macugen, please visit http://www.bausch.com/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals/macugen-pegaptanib-sodium-injection.

Important Safety Information

Macugen is contraindicated in patients with ocular or periocular infections.

Intravitreal injections including those with Macugen have been associated with endophthalmitis. Proper aseptic injection technique -- which includes use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) -- should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been seen within 30 minutes of injection with Macugen. Therefore, IOP as well as the perfusion of the optic nerve head should be monitored and managed appropriately.

Serious adverse events related to the injection procedure occurring in Most frequently reported adverse events in patients treated for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients.

Source: Eyetech Pharmaceuticals, Inc.

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