Macugen effects sustained for 2 years in AMD study

This year's American Academy of Opthalmology meeting is being held in New Orleans.

NEW ORLEANS — A drug that inhibits vascular endothelial growth factor showed good preservation of vision at 2 years in a study in patients with age-related macular degeneration. Vision preservation was better in patients who were treated for 2 years than in those treated for 1 year, according to data presented here at the American Academy of Ophthalmology meeting.

Steven Schwartz, MD, presented the outcomes of the phase 3 study of Macugen during the retina subspecialty day here.

“There was virtually no loss of visual acuity for the Macugen (pegaptanib sodium injection) group in the second year of therapy,” Dr. Schwartz said.

“[The new data] confirm that treatment with Macugen is effective in patients with neovascular AMD who are at risk of losing their vision,” said David R. Guyer, MD, chief executive officer of Eyetech Pharmaceuticals, in a press release.

“Two-year data on Macugen demonstrate that longer term use may be beneficial for patients suffering from this chronic disease,” he added.

In phase 2/3 of the multicenter trial, 1,186 patients were randomized to receive 0.3 mg, 1 mg, or 3 mg of Macugen or sham injection every 6 weeks for 1 year. At 1 year, 1,053 patients were randomized either to continue treatment for a second year or not.

In patients who received 0.3 mg of Macugen for 2 years, there was 45% treatment benefit over standard care (P < .05), Dr. Schwartz said.

Dr. Schwartz said Macugen was beneficial in preserving vision and well tolerated after 2 years of treatment.

A new drug application for Macugen has been filed with the Food and Drug Administration. The drug has received priority review status.