Health Canada granted approval for Macugen (pegaptanib sodium injection) for the treatment of subfoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (‘wet’ AMD). Macugen is the first therapy indicated in Canada for the treatment of subfoveal neovascular AMD regardless of lesion subtype or size.
It is expected that Canadian ophthalmologists will start treating patients with Macugen later this year. Macugen has also been filed for approval in the European Union, Australia, Switzerland and Brazil.
In a separate announcement, Eyetech unveiled imaging data from a phase II study of Macugen in diabetic macular edema (DME), showing a reversal of capillary microaneurysms, retinal ischemia and neovascularization – all important signs of diabetic retinopathy.
Eyetech and Pfizer plan to conduct a pivotal phase II/III DME clinical trial that will include the diabetic retinopathy score as a pre-specified secondary endpoint. This trial is expected to begin in the second half of 2005.