The treatment effect with Eyetech Pharmaceuticals' investigational drug Macugen (pegaptanib sodium injection) extends for two years in patients with neovascular or wet, age-related macular degeneration (AMD), who are at risk of losing their vision. A treatment benefit was also seen for patients who received Macugen for two years compared to those only receiving one year of therapy. The data confirm that patients benefit from two years of treatment with Macugen for wet AMD.
Eyetech and Pfizer are partnering to develop and market Macugen, a treatment for neovascular or wet AMD, the leading cause of severe vision loss in patients older than 50 years of age in the developed world. Eyetech and Pfizer have filed an NDA for Macugen for neovascular AMD with the FDA. Macugen has been assigned priority review status and the PDUFA date is December 17, 2004.
"We are excited about the new data because they confirm that treatment with Macugen is effective in patients with neovascular AMD who are at risk of losing their vision," David R. Guyer, chief executive officer, Eyetech Pharmaceuticals said adding, "The two year data on Macugen demonstrate that longer term use may be beneficial for patients suffering from this chronic disease," he added.
These data are from two, pivotal phase II/III randomized, multi-centre, double-masked studies in patients with all subtypes of neovascular AMD. 1,186 patients were initially randomized to receive one of three doses of intravitreous Macugen or sham (control) injection every six weeks for 54 weeks. Thereafter patients were re-randomized to continue or discontinue treatment for a further year. The second year of the study, which included 1053 patients, was designed to investigate the need for continued chronic treatment beyond one year and to establish the safety of longer term treatment, the company release said.
In those patients who continued on therapy for two years, the positive effect of Macugen was statistically significant at two years, where there was an approximately 45 percent treatment benefit in patients being administered Macugen 0.3mg compared to usual care controls (mean vision -17.0 letters in usual care controls Vs -9.4 letters in treated eyes; p is less than or equal to 0.05).
The mean number of injections for the patients completing two years of therapy was 15.6 out of a possible 17 injections, indicating a high rate of compliance (92 per cent) throughout the two years of treatment.
In the arm of the study designed to evaluate chronic treatment, 67 per cent more events (three line loss) were noted in patients who were limited to one year therapy as compared to those who received continuous therapy for two full years, which was statistically significant (21 events for the two year group Vs 35 events for the one year group; p is less than or equal to 0.05), suggesting that therapy of two years compared to one year is beneficial for this chronic disease, the release added.
Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF).
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye.