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Eyetech Pharmaceuticals, Inc. announces macugen data on treating macular degeneration

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.

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<.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 percent) throughout the two years of treatment.

In the arm of the study designed to evaluate chronic treatment, 67 percent 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<.05), suggesting that therapy of two years compared to one year is beneficial for this chronic disease.

Based on preliminary analyses of the safety data, Macugen is well-tolerated after two years of treatment. The safety profile of the second year was similar to that of the first year, and no new safety concerns were identified. Most of the adverse events were mild, transient and attributed by investigators to the injection procedure rather than the study drug. Serious adverse events generally related to the injection procedure included endophthalmitis, retinal detachme
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21-Oct-2004


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