A second Phase III study has found that Genentech’s new drug to treat age-related macular degeneration – a leading cause of blindness – is more effective than the standard photodynamic treatment Visudyne from Novartis.
Interim results from the head-to-head ANCHOR trial show that after a year’s treatment, patients with the wet form of AMD who were given Lucentis (ranibuzumab) had better visual acuity than those who received Visudyne (verteporfin).
There was a difference in mean change in visual acuity of 18 letters on a reading chart for patients treated with 0.3 mg of Lucentis and 21 letters for patients treated with 0.5 mg of Lucentis from study entry compared to those treated with Visudyne at 12 months.
The trial defines maintaining vision as a loss of less than 15 letters, and Lucentis is already far superior, actually improving visual acuity by 8.5 to 11 letters while the Visudyne group declined by an average of 9.5 letters.
Genentech has commercial rights for Lucentis in North America (the USA, Canada and Mexico), while Novartis has rights for the rest of the world.
In December 2005, Genentech filed for approval of Lucentis with the US Food and Drug Administration, and has been granted a six-month priority review for the application.
If approved for Lucentis will be the third product to be specifically approved in this use. Visudyne, originated by Canadian company QLT, was the first to reach the market. It was joined last year by Pfizer/OSI pharmaceuticals' Macugen (pegaptanib), which like Lucentis is a vascular endothelial growth factor (VEGF) receptor blocker, but so far has not been shown to improve visual acuity in trials. OSI acquired Macugen along with Eyetech Pharmaceuticals last November.
At present, the market for AMD therapies is valued at around $600 million dollars, with Visudyne dominating the sector with sales of around $450 million last year.