Abstract
In today's Lancet, a Comment about the new treatments for age-related macular degeneration (AMD), draws together efficacy and safety data for pegaptanib and ranibizumab, and for the anticancer agent bevacizumab (a relative of ranibizumab), which is used off-label for AMD on the basis of doctors' experiences of results. Tien Wong and colleagues, who wrote the Comment, put it mildly: “Intravitreal bevacizumab in particular presents a new dilemma—this is an apparently effective, cheap but unlicensed drug, which is promoted by physicians rather than drug companies, and demanded by patients. However, clinical trial evidence to support its use and delineate any harms is not available.”A comparison of bevacizumab with ranibizumab, funded by the National Eye Institute, is planned in the USA. But the manufacturers of bevacizumab—Genentech—do not plan to develop the drug for AMD. Why? Perhaps because they also make the far more expensive ranibizumab, so it might not be in their financial interest to put bevacizumab through clinical trials and seek a licence.Last month, the UK's National Institute for Health and Clinical Excellence (NICE), which covers England and Wales, released draft guidance for the treatment of AMD with intravitreal pegaptanib and ranibizumab. NICE, set up to advise the Government on the cost-effectiveness of medical interventions, says that pegaptanib is not cost effective and that ranibizumab might be, but only for patients with AMD in both eyes and then only for treatment of the least-affected eye.Patients and patients' groups do not take NICE's decisions lying down. The AMD Alliance—a global non-profit coalition of AMD-related patients' organisations—has launched a campaign against the preliminary NICE guidance. Its website reads: “British AMD patients facing draconian situation—cruel watchdog is condemning 20 000”. But no similar campaign has been launched to lobby Genentech and the companies involved in marketing bevacizumab or ranibizumab to fund a trial comparing the two. Such a move would show that the AMD Alliance is serious about exploring all possibilities for people with AMD. In today's Lancet, a Comment about the new treatments for age-related macular degeneration (AMD), draws together efficacy and safety data for pegaptanib and ranibizumab, and for the anticancer agent bevacizumab (a relative of ranibizumab), which is used off-label for AMD on the basis of doctors' experiences of results. Tien Wong and colleagues, who wrote the Comment, put it mildly: “Intravitreal bevacizumab in particular presents a new dilemma—this is an apparently effective, cheap but unlicensed drug, which is promoted by physicians rather than drug companies, and demanded by patients. However, clinical trial evidence to support its use and delineate any harms is not available.” A comparison of bevacizumab with ranibizumab, funded by the National Eye Institute, is planned in the USA. But the manufacturers of bevacizumab—Genentech—do not plan to develop the drug for AMD. Why? Perhaps because they also make the far more expensive ranibizumab, so it might not be in their financial interest to put bevacizumab through clinical trials and seek a licence. Last month, the UK's National Institute for Health and Clinical Excellence (NICE), which covers England and Wales, released draft guidance for the treatment of AMD with intravitreal pegaptanib and ranibizumab. NICE, set up to advise the Government on the cost-effectiveness of medical interventions, says that pegaptanib is not cost effective and that ranibizumab might be, but only for patients with AMD in both eyes and then only for treatment of the least-affected eye. Patients and patients' groups do not take NICE's decisions lying down. The AMD Alliance—a global non-profit coalition of AMD-related patients' organisations—has launched a campaign against the preliminary NICE guidance. Its website reads: “British AMD patients facing draconian situation—cruel watchdog is condemning 20 000”. But no similar campaign has been launched to lobby Genentech and the companies involved in marketing bevacizumab or ranibizumab to fund a trial comparing the two. Such a move would show that the AMD Alliance is serious about exploring all possibilities for people with AMD. Clinical update: new treatments for age-related macular degenerationAge-related macular degeneration (AMD) is the leading cause of vision loss in the developed world. Until recently, this condition was believed to be largely untreatable, but developments in the past 2 years have challenged this view. A new class of drugs—based on suppression of vascular endothelial growth factor (VEGF)—has been introduced for the treatment of “wet” or neovascular AMD, the most visually disabling form (table 1).1–4 In 2006, results with an anti-VEGF agent, ranibizumab, showed that monthly intravitreal injections prevented vision loss and, in many cases, significantly improved the visual acuity of patients with neovascular AMD. Full-Text PDF
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