Visudyne verteporfin: Phase III; Marketed to treat predominantly classic subfoveal CNV caused by age-related macular degeneration (AMD)

Novartis AG (NVS; SWX:NOVN, Basel Switzerland) and QLTI said that two-year data from a placebo-controlled Phase IIIb trial of Visudyne therapy in 339 patients with subfoveal CNV, showed that 46 percent of patients treated with Visudyne lost less than 3 lines of vision (15 characters) compared to 33 percent of patients receiving placebo (p=0.023). The 13 percent difference at two years is greater than the 4 percent difference at 12 months, which was not statistically significant. In the North American and European trial, 70 percent of patients on Visudyne lost less than 6 lines of vision (30 characters) compared to 53 percent of placebo patients (p=0.001). Again, the difference at 12 months had not been statistically significant. A subgroup of patients with CNV without classical components, who comprised about 75 percent of the patients enrolled, had very similar results, with a of loss of less than 3 lines of vision in 45 percent of the Visudyne group versus 31 percent for placebo (p=0.03) and loss of less than 6 lines of vision in 71 percent on Visudyne versus 53 percent on placebo (p=0.004). NVS said that Visudyne therapy works best in patients with relatively small lesions or lower levels of visual acuity, and may not be beneficial for patients presenting with both large lesions and good visual acuity. ...