Macugen demonstrates good visual results after 24 months

October 22, 2004

The VEGF (vascular endothelial growth factor) Inhibition Study in Ocular Neovascularization (VISION), a phase III appraisal of three doses of pegaptanib sodium injection (Macugen, Eyetech Pharmaceuticals) (0.3, 1, and 3 mg) compared with a sham procedure, found that the 0.3-mg dose of Macugen improves visual outcomes in patients with age-related macular degeneration.

New Orleans-The VEGF (vascular endothelial growth factor) Inhibition Study in Ocular Neovascularization (VISION), a phase III appraisal of three doses of pegaptanib sodium injection (Macugen, Eyetech Pharmaceuticals) (0.3, 1, and 3 mg) compared with a sham procedure, found that the 0.3-mg dose of Macugen improves visual outcomes in patients with age-related macular degeneration. VISION consisted of two randomized, double-masked controlled dose-ranging trials that included 1,190 patients at 117 centers worldwide. The patients had all subtypes of neovascularization.

Eight hundred ninety patients received an injection of pegaptanib sodium injection every 6 weeks, and 296 patients received usual care for AMD. Steven Schwartz, MD, of Jules Stein Eye Institute, Los Angeles, reported at retina subspecialty day at the American Academy of Ophthalmology annual meeting that "Macugen had an early and sustained effect, and demonstrated an approximately 50% greater effect compared with the controls."

Six weeks after treatment patients who received pegaptanib sodium injection gained 2.5 letters more than controls (p = 0.0069): at 12 weeks, 3.1 letters (p = 0.0037), and at 54 weeks, 7 letters (p

There was no evidence of drug-related ocular or systemic safety problems possibly because pegaptanib sodium injection specifically targets VEGF 165, the isoform associated with pathologic neovascularization, and spares normal vessels. In addition, the drug is delivered locally and clears rapidly from the systemic circulation. Twelve patients (1.3%) developed endophthalmitis and one of them had severe vision loss.