Pfizer, OSI Pharmaceuticals' Macugen approved for treatment of macular degeneration in Europe

By Angela McDaniels

Seattle, Feb. 2 - Pfizer Inc. said the European Commission has granted marketing authorization for Macugen (pegaptanib sodium injection) for the treatment of neovascular or "wet" age-related macular degeneration, the leading cause of irreversible severe vision loss in patients older than 50 years of age in developed countries.

"Macugen is the first therapy indicated in Europe for the treatment of all types of wet age-related macular degeneration, regardless of lesion subtype, size or visual acuity," chief medical officer Joseph Feczko said in a company news release.

The approval was based on clinical results from two pivotal clinical trials involving 1,186 patients with all subtypes of the disease. Pfizer said that Macugen prevented severe vision loss at twice the rate of standard care, which included photodynamic therapy.

Macugen was well tolerated, according to the release. Patients on Macugen for two years received over 90% of possible injections, indicating strong compliance and acceptance to therapy.

"While the problem of wet age-related macular degeneration is a global one, it hits particularly hard in areas with rapidly aging populations, such as Europe," Steve Winyard, chairman of the Age-related Macular Degeneration Alliance International, said in the release.

"Each year there are an estimated 500,000 new cases of wet age-related macular degeneration worldwide, so new treatment options are crucially important."

Wet age-related macular degeneration is a chronic, progressive disease of the macula, the central portion of the retina. Central vision is impaired when abnormal blood vessel growth beneath the macula causes bleeding and other fluid accumulation in the retina.

Pfizer said Macugen is the first of a new type of ophthalmic drug that targets vascular endothelial growth factor. By selectively binding to this growth factor, Macugen reduces blood vessel growth and leakage, thereby limiting the progression of vision loss.

Pfizer gained the exclusive license to develop and market Macugen outside of the United States from OSI Pharmaceuticals Inc. The companies will jointly develop and market Macugen in the United States.

Macugen has been approved by regulatory authorities in the United States, Canada, Brazil, Argentina, Peru, Pakistan and the Philippines, with filings submitted in 15 other countries including Australia, Switzerland and Mexico.

More than 50,000 patients with wet age-related macular degeneration have been treated with Macugen in the United States, the company said.

Pfizer is a pharmaceutical company based in New York.

OSI Pharmaceuticals is a Melville, N.Y.-based company that develops drugs for the treatment of cancer, eye diseases and diabetes.

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