Retinal disease AMD

16.04.2010 17:52

Treat effectively and safely

Age-related macular degeneration (AMD) is one of the most common causes of blindness in industrialized nations. The wet form of this retinal disease can be effectively treated with medication. The drug Lucentis is approved for this purpose, while Avastin, which is not approved for the treatment of AMD, is used off-label.

The German Ophthalmological Society (DOG) and the Retinological Society (RG) are calling for free access to scientifically proven medications, emphasizing drug safety and evidence-based medicine. The experts also advocate a transparent, nationwide approach by the health insurance companies, which, in the interests of patients, allows timely initiation of therapy without bureaucratic hurdles.

According to the DOG, age-related macular degeneration is the most common cause of visual impairment and blindness: around 4.5 million people are affected by it in Germany alone. 50,000 people fall ill with the particularly dangerous “wet” form every year. With Lucentis, developed for AMD therapy, and Avastin, originally developed to treat colon cancer, two effective medications are now available.

Their respective active ingredients – ranibizumab and bevacizumab – are chemically closely related and their modes of action are similar: when introduced into the eyeball, they inhibit a messenger substance that plays an essential role in the disease: the so-called vascular endothelial growth factor (VEGF). If left untreated, the increased production of VEGF leads to leaky blood vessels growing into the retina and destroying the visual cells.

Ranibizumab and bevacizumab are effective in reversing vision loss in the majority of patients with wet AMD, DOG and RG explain in a statement. “In around a third of patients there is even an improvement,” says Professor Dr. med. Peter Wiedemann, Vice President of the DOG and Director of the Eye Clinic at Leipzig University Hospital. For Lucentis, the effectiveness and safety have been proven by extensive so-called phase III studies as part of an approval process.

Avastin is not approved for use in AMD therapy, which is why doctors can only use it for so-called “off-label use” outside of the actual approval. However, from a pharmaceutical law perspective, this is not without problems, especially when an approved preparation is available, and entails liability risks for the treating doctor.

Some health insurance companies even support the use of the cheaper off-label preparation with more attractive medical fees. “Free access to scientifically tested medications must be guaranteed, even when treatment alternatives are indicated, otherwise the system will not do justice to the great value of drug safety and evidence-based medicine,” says Professor Dr. med. Frank G. Holz, director of the University Eye Clinic in Bonn.

The specialist societies have recently dealt with the topic in detail. “With the joint statement of the Retinological Society, the German Ophthalmological Society and the Professional Association of Ophthalmologists, we have clearly identified the key points of the treatment of wet macular degeneration,” emphasizes Professor Dr. med. Ulrich Bartz-Schmidt, President of the Retinological Society.

The focus for the scientific societies is to provide the best possible care for patients. It therefore calls for all those affected to have access to anti-VEGF therapy that is effective and safe and on a nationwide, uniform, transparent contractual basis.