Macugen appears promising for all types of AMD, surgeon says

ANAHEIM, Calif. — In an ongoing phase 3 clinical trial, Macugen has so far shown efficacy and safety in treating all subtypes of age-related macular degeneration; according to a presenter here.

Macugen, an anti-vascular endothelial growth factor (VEGF) pegylated aptamer developed by EyeTech, targets the underlying cause of age-related macular degeneration (AMD) by inhibiting the effect of ocular VEGF, said Carmen A. Puliafito, MD, MBA. Dr. Puliafito presented an update on the Macugen Collaborative Trial here at the American Academy of Ophthalmology meeting.

“This study is actually the largest randomized clinical trial for neovascular AMD ever performed, with almost 1,200 patients enrolled,” he said. “We are apparently on the verge of a new treatment era in macular degeneration therapy.”

The drug has so far shown a good safety profile, with few serious adverse events, Dr. Puliafito said. Endophthalmitis has been rare, with 12 cases in more than 7,500 injections. A small number of retinal detachments and no serious systemic side effects have been seen, he said.

Dr. Puliafito said the study has been noteworthy not only for the high number of patients enrolled but also for the potentially far-reaching benefits of the drug. He noted that visual acuity either remained stable or improved in 33% of patients in all categories.

“An important observation is that the benefit of Macugen is independent of lesion subtype. There was less vision loss in all categories” with use of the drug, he said.

He further noted that Macugen works quickly. At 6 weeks follow-up in the phase 3 trial (now at 52 weeks), patients loss 1.5 letters in the treatment group vs. 4 letters in the sham treatment group. The inclusion criteria for patients were vision of 20/40 to 20/230 with lesion sizes as large as 12 disc diameters, Dr. Puliafito told attendees.