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Friday, October 06, 2006

NICE's delay could blind thousands with AMD

A drug for treating the disease which is the biggest cause of sight loss in the UK could also help people regain some vision, research suggests. Injections of the drug Lucentis can improve sight in people with a particular form of retina degeneration. Although the drug Lucentis has been given a US licence, NICE's hold up will mean that thousands of UK sufferers of AMD will be denied access for their failing sight.

A study involving 716 people in the New England Journal of Medicine found it slowed vision loss in 90% of patients, and improved vision for about a third. The drug has yet to be granted a European licence.

The Macular Disease Society said it was vital Lucentis was granted a Europe-wide licence and treatment was funded by the NHS as soon as possible. "It is a treatment that is effective within the first few weeks of onset of Wet AMD. If funding by primary care trusts is delayed until Nice complete their review then thousands of people could lose their sight irreversibly."

Lucentis (ranibizumab), which is used to treat wet age-related macular degeneration (wet AMD), will be appraised by the National Institute for Health and Clinical Excellence (Nice).
However, it has already been approved for use in the US.

The drug, one of a class known as anti-angiogenics, prevents the formation of abnormal, new blood vessels in the eye, and dries up vessels which have already begun to leak.

Eye tests

The 716 patients who took part in the study were given eye chart tests before and after receiving the drug, or a placebo.

Stude Findings

After two years patients taking 0.3mg of Lucentis were able to read on average 5.4 more letters on the sight chart. Patients taking 0.5mg were able to read 6.6 more letters. Patients given a placebo drug were able to read 14.9 fewer letters

Overall, nine out of 10 of those given the drug lost fewer than 15 of the letters on the chart two years after starting treatment. This compared with five out of 10 of the patients given a placebo.

A quarter (26%) of those receiving 0.3mg of the drug and 33% of those receiving 0.5mg also experienced improvements in their sight, compared with 4% on the placebo.

This meant they could read an additional three lines or 15 or more letters on an eye chart after a course of treatments.

Another drug, Macugen, and photodynamic therapy can halt the advance of AMD.

And there is preliminary evidence that Avastin, a drug used to treat cancer, may also potentially restore vision in a way similar to Lucentis, but at a cheaper cost.

Steve Winyard, of the Royal National Institute for the Blind (RNIB), said the results were "very exciting".

He added: "Thousands of people a year in the UK get wet AMD and it rapidly leads to sight loss. This drug is particularly exciting because it can treat all types of AMD. Although this is not a cure, ranibizumab is great news for individual patients as it offers them the chance of having their vision restored."

Widespread problem

Wet AMD is the leading cause of blindness in the UK, with thousands of new cases every year.

About 20,000 people in the UK are estimated to suffer from wet AMD, while up to 500,000 suffer from both the wet and dry forms of the condition.

AMD affects the macular - the central part of the retina at the back of the eye that is responsible for the central vision necessary for everyday activities like reading, driving, telling the time or identifying faces.

Winfried Amoaku, a consultant ophthalmologist and member of the Royal College of Ophthalmologists' scientific committee, said: "This study on Lucentis is the first to show vision improvement in patients with wet AMD.

"Previous studies have demonstrated that other treatments can help maintain vision."

However, he said there was no data directly comparing Lucentis to other similar treatments.

For more news on AMD and the Macular Disease Society, please see:


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