Macugen three-year safety

December 3, 2008

Pegaptanib sodium therapy is safe in patients with neovascular age-related macular degeneration (NV-AMD) up to three years, according to study results published in the December issue of the British Journal of Ophthalmology.

Pegaptanib sodium therapy (Macugen) is safe in patients with neovascular age-related macular degeneration (NV-AMD) up to three years, according to study results published in the December issue of the British Journal of Ophthalmology.

Dr Lawrence J. Singerman of the Retina Associates of Cleveland, Ohio, US and colleagues conducted two concurrent prospective, multicentre, double-masked randomized studies of NV-AMD patients treated intravitreally with either pegaptanib sodium (0.3, 1 or 3 mg) or a sham injection every six weeks for 54 weeks, after which subjects discontinued treatment or were randomized for a further 48 weeks of treatment. At week 102, patients receiving the two lower doses of pegaptanib in either of the earlier treatment periods continued; patients from the 3 mg pegaptanib and sham groups were randomized to either 0.3 or 1 mg of pegaptanib.

Pegaptanib was well-tolerated, with mild, transient adverse events related to injection and very few serious adverse events. Pegaptanib was not found to influence electrocardiogram results, and no adverse events related to inhibition of vascular endothelial growth factor were recorded.

Thus the study concluded that pegaptanib was a safe treatment at three years, with limited and usually mild adverse events.