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An American drug company is facing criticism from ophthalmologists for allegedly denying the legitimate use of a cheap and effective treatment for macular degeneration, in favour of a more expensive drug.

The Guardian (June 17) reported that some ophthalmologists were injecting tiny quantities of the colon cancer drug Avastin into patients’ eyes as a treatment for wet age-related macular degeneration (AMD). The results have been described as ‘remarkable’ and the cost is very little since one phial is enough to treat dozens of eyes.

A decade ago Genentech, the US company that makes Avastin, developed Lucentis, a ‘fragment’ of Avastin designed specifically for use in eyes. The NHS’s National Institute for Health and Clinical Excellence (Nice) is expected to decide whether Lucentis and another AMD drug, Macugen, should be available on the NHS in 2008.

The accusation is that Lucentis will be vastly more expensive than Avastin and that Genentech is not willing to trial and license Avastin for AMD treatment. Nice cannot consider Avastin for AMD use in the NHS if there is no licence for its use.

One of the main proponents of the use of Avastin for AMD is Philip Rosenfeld, associate professor of ophthalmology at the University of Miami.

This unlicensed or ‘off-label’ use of Avastin has grown in popularity with ophthalmologists worldwide. But while around 7,000 eyes have been treated with significant success, regulators require randomised controlled trials before they grant licences.

Only the drug companies involved can afford to carry out such trials.

In the Guardian article, Rosenfeld described Avastin as a ‘wonder drug’ but accused drug companies of being greedy. He proposed that governments fund clinical trials that are in the public interest.

A spokeswoman for Genentech told Optician that it had taken 10 years to get to the current position where Lucentis is up for approval by regulators.

The biotechnology company also expressed concerns that safety data on the use of Avastin for AMD are not being collected in a ‘standard or organised’ fashion.

A spokeswoman for Roche, which supplies Avastin in the UK, said it could not comment on off-label use of its products.

Bill Harvey, clinical editor of Optician commented: ‘In the current climate you can fully understand a drug company’s reluctance to allow the promotion of any unlicensed use of a drug.

But until fully controlled clinical trials of Avastin for AMD use are set up in Europe, one cannot dismiss that financial considerations are behind their reasoning.’

rob.moss@rbi.co.uk

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