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Two Phase III clinical studies have shown that injections of VEGF Trap every eight weeks were as effective as injections of Lucentis® every four weeks in the treatment of wet age-related macular degeneration (AMD). VEGF Trap is an emerging treatment for wet AMD being developed by Regeneron and Bayer. The developers’ two Phase III clinical trials involved a total of 2,457 participants. Lucentis has been considered the gold standard for wet AMD treatment since it was approved by the FDA in 2006, but both patients and doctors agree that reducing the frequency of intraocular injections required for wet AMD treatment would be highly desirable. “Reducing the frequency of treatment injections is not only more convenient, it reduces the risk of complications in the long run.” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “Experts have reported that most patients with wet AMD need monthly injections of Lucentis, especially when they first begin treatment. Reducing the frequency by 50 percent would be significant.” In Regeneron-Bayer’s 52-week U.S. study of 1,217 people, 95.1 percent of participants receiving VEGF Trap (2.0 m.g.) every eight weeks had their vision maintained. In comparison, 94.4 percent of participants receiving Lucentis (0.5 m.g.) every four weeks had their vision maintained. The same group of participants receiving VEGF Trap had a mean improvement in vision of 7.9 letters. The same group of participants receiving Lucentis had a mean improvement in vision of 8.1 letters. Results for Regeneron-Bayer 52-week international study of 1,240 people were similar to results in their U.S. study. Both Lucentis and VEGF Trap work by blocking Vascular Endothelial Growth Factor (VEGF), a protein that causes the proliferation of leaky, vision-robbing blood vessels underneath the retina in people with wet AMD. VEGF Trap also blocks Placental Growth Factor (PIGF), another protein that leads to the growth of unhealthy blood vessels. Regeneron and Bayer are planning to submit regulatory applications for VEGF Trap marketing approval in the U.S. and Europe in the first half of 2011. |
