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Aflibercept in macular oedema: added benefit not proven

Neither the new drug nor the comparator therapy was used in accordance with their approvals in the studies.

For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG) dealt with the drug aflibercept. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute now examined whether aflibercept (trade name: Eylea) offers an added benefit over the appropriate comparator therapy in visual impairment due to macular oedema following occlusion of the central retinal vein.

An added benefit could not be derived from the dossier because in the studies cited by the drug manufacturer, both aflibercept and the comparator therapy were not used in accordance with their approvals.