The Pharmaceutical Journal
Vol 277 No 7423 p475
21 October 2006

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Ranibizumab studies reveal drug's efficacy in AMD

Treatment with a new vascular endothelial growth factor — ranibizumab — prevents vision loss and improves mean visual acuity in patients with neovascular age-related macular degeneration, according to the results from two trials published in The New England Journal of Medicine this month (2006;355:1419 and 1432).

The first trial involved 716 patients with minimally classic or occult chorioidal neovascular age-related macular degeneration, who received intravitreal injections of ranibizumab (either 0.3mg or 0.5mg) or sham injections for two years.

At 12 months, 94.5 per cent of the group given 0.3mg and 94.6 per cent of the group given 0.5mg ranibizumab lost fewer than 15 letters from baseline visual acuity compared with 62.2 per cent of patients in the control group (P<0.001). In addition, visual acuity improved by 15 or more letters in 24.8 per cent of the 0.3mg group and 33.8 per cent of the 0.5mg group compared with 5 per cent of the control group (P<0.001). This benefit in visual acuity was maintained at 24 months, say the authors.

The rates of serious adverse events were low with presumed endophthalmitis occurring in 1 per cent and uveitis occurring in 1.3 per cent of patients receiving ranibizumab.

Similar results were achieved in the second trial, which compared ranibizumab with photodynamic therapy with verteporfin in 423 patients with predominantly classic neovascular age-related macular degeneration. After 12 months, 94.3 per cent of those in the 0.3mg ranibizumab group and 96.4 per cent of those in the 0.5mg ranibizumab group lost fewer than 15 letters compared with 64.3 per cent of those in the verteporfin group (P<0.001). Visual acuity improved by 15 letters or more in 35.7 per cent of the 0.3mg ranibizumab group and 40.3 per cent of the 0.5mg ranibizumab group, compared with 5.6 per cent of the verteporfin group (P<0.001). The rate of endophthalmitis was 1.4 per cent and serious uveitis was 0.7 per cent in patients treated with the higher dose of ranibizumab.

The author of an accompanying editorial (ibid, p1493) comments that, although the results are exciting, several questions remain. He explains that a growing body of anecdotal and retrospective data suggests that bevacizumab is an effective treatment for age-related macular degeneration, and it is a tenth of the cost of ranibizumab. He believes that a head-to-head trial is warranted. He also suggests that an induction and follow-up strategy should be investigated to confirm whether choroidal neovascularisation could be treated with fewer injections.

The National Institute for Health and Clinical Excellence is currently conducting a technology appraisal of ranibizumab for age-related macular degeneration and expects to publish recommendations in August 2007.