The efficacy of colon cancer drug Avastin (bevacizumab) in treating wet-AMD could be compared to wet-AMD drug Lucentis (ranibizumab) in a US government clinical study.
This is according to US reports in the same week that 'striking' new research, widely reported in the national media today, has confirmed Lucentis's success rate.
The US National Eye Institute has approved the trial in principle, subject to resolving how to pay for it, clinical director Frederick Ferris told Bloomberg.com this week.
Genentech, the biotechnology company that developed both drugs, has come under criticism from ophthalmologists for allegedly denying the legitimate wet-AMD use of the much cheaper Avastin, in favour of Lucentis, the drug it developed specifically for this purpose (News, June 23). Lucentis is reported to cost 100 times more than Avastin.
Ferris said there were obviously public health reasons for such a study. 'The National Eye Institute in conjunction with others is looking into whether we can do that,' he said, 'but there remain some major issues regarding funding because this is a very expensive study.'
Ferris said that the study had already cleared the first hurdle - peer review - and that the US National Advisory Eye Council had concurred.
Meanwhile research published today in the New England Journal of Medicine has shown Lucentis is the first wet-AMD treatment to significantly improve vision in large-scale Phase III clinical trials.
Yit Yang, a consultant ophthalmologist at Wolverhampton & Midland Eye Infirmary said: 'These results are very striking. With ranibizumab we will have the opportunity, at least in cases treated without delay, of reversing the visual loss and maintaining the improved vision for up to two years or longer.'
Data from the MARINA trial, one of two studies reported, show that over two years ranibizumab prevented significant visual loss or actually improved vision in nine out of 10 patients with certain types (minimally classic and occult) of wet AMD versus five out of 10 patients in the placebo controlled group.
Furthermore, over a third of patients treated with the 0.5mg ranibizumab dose experienced a marked visual improvement of at least 15 letters or more versus less than one in 25 in the placebo controlled group.
Steve Winyard, director of public policy at the RNIB, said: 'Although this is not a cure, ranibizumab is great news for individual patients, as it offers them the chance of improving their vision. This means that potentially people with wet AMD can become independent again.'
The National Institute for Health and Clinical Excellence (Nice) is expected to reach a decision on the approval of Lucentis, sold in the UK by Novartis Pharmaceuticals, late next year.
Other links
Genentech letter to practitioners warning of the potential safety risks of off-label use of Avastin for AMD
Today's Lucentis coverage in the national media
BBC News
The Guardian
The Independent
The Times
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