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Macugen shows benefit through second year of treatment for AMD
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MONTREAL — Two years of treatment with pegaptanib provided sustained benefit for patients with age-related macular degeneration, according to a physician speaking here. Donald J. D’Amico, MD, said patients receiving pegaptanib had better visual outcomes at the 2-year follow-up point than those who received sham treatment.
Dr. D’Amico presented data here at the American Society of Retina Specialists meeting on the 2-year results in patients treated with Macugen (pegaptanib sodium for injection, Eyetech/Pfizer) and compared those data to the 1-year follow-up results. Of an initial 1,190 patients treated with Macugen, 1,053 who had received at least one treatment continued into year 2, Dr. D’Amico said.
Patients continued to receive treatment with Macugen 0.3 mg in the second year of the trial demonstrated a continued benefit over those who had never received the drug, “indicating a 45% relative benefit in treatment,” Dr. D’Amico said. In addition, he said, compliance during the second year of the trial was “quite high,” with the average patient receiving 16 of a possible 17 injections.
Comparing patients who received Macugen for 2 years with those received only 1 year of treatment, Dr. D’Amico said “there are fewer major vision loss events in [the Macugen] group compared with those people who are withdrawn from Macugen therapy, who experience 35 vision loss events.”
Patients with initial leakage “have a much higher tendency to demonstrate leakage if Macugen therapy is withdrawn,” Dr. D’Amico said.
Of patients who completed year 2 of Macugen treatment, 35% had the same visual acuity as at baseline or had improved during the second year of treatment. Patients who were treated with Macugen 0.3 mg for a second year showed a mean visual acuity loss of 9.4 letters on an eye chart, compared with a loss of 17 letters in those who did not receive Macugen.
Among those who completed 2 years of treatment, 78 of 133 patients (59%) who received Macugen 0.3 mg lost fewer than 15 letters, compared with 48 of 107 (45%) receiving sham treatment.
According to Dr. D’Amico, “67% more occurrences of a three-line loss of vision were noted in patients receiving but 1 year of therapy compared to those receiving 2 years of therapy.”
In addition, Dr. D’Amico said, no new systemic or ocular safety concerns emerged in the second year of treatment, and the incidence of endophthalmitis decreased.