OSI, Pfizer three-year trial data review shows Macugen safe

By Lisa Kerner

Erie, Pa., Feb. 24 - OSI Pharmaceuticals, Inc. and Pfizer Inc announced that the previously established systemic safety profile of Macugen (pegaptanib sodium injection) was maintained over two years of treatment with no evidence of an association with hypertension, serious hemorrhagic (excessive bleeding) events or thromboembolic (blood clots) events as compared to the control group.

A preliminary analysis of a third year of data suggests that the safety of Macugen is maintained throughout three years of treatment, according to a company news release.

These data were presented at the annual Macula Society meeting on Feb. 22 to Feb. 25 in California.

OSI said Macugen is the only VEGF inhibitor with long-term safety data in neovascular age-related macular degeneration (AMD), and the only VEGF inhibitor that specifically targets VEGF 165, the isoform primarily responsible for promoting the blood vessel growth and leakage associated with neovascular AMD.

AMD is a chronic, progressive disease of the central portion of the retina called the macula, resulting in the loss of central vision, the release stated.

"These long-term safety data are of utmost importance because wet AMD afflicts people over the age of 65, an age group already at increased risk of cardiovascular disease, including heart attack and stroke," said Larry Singerman, clinical professor of ophthalmology at Case University School of Medicine, in the release.

"Macugen's proven systemic safety profile over two years is encouraging because many of our patients require long-term treatment since AMD is a chronic, progressive disease."

Data presented at the Macula Society meeting are from the two Macugen trials, jointly known as Vision. The concurrent multicenter, double-masked, randomized controlled studies enrolled 1,190 patients.

After two years, patients receiving 0.3 mg or 1 mg of Macugen continued on the same dose for a third year; all remaining subjects were re-randomized either to 0.3 mg or to 1 mg for a third year. Of the 422 patients entered into the third year of the trials, 161 patients received Macugen for three years.

The safety profile of Macugen was maintained over three years, with no new ocular or systemic safety concerns, according to the release.

OSI discovers, develops and commercializes novel pharmaceutical products for the treatment of cancer, eye diseases and diabetes. The company is based in Melville, N.Y.

New York-based Pfizer Inc. discovers, develops, manufactures and markets leading prescription medicines for humans and animals.

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