Bayer has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a high-dose formulation of Eylea, a popular eye drug. This recommendation specifically applies to the treatment of two major retinal eye diseases: wet age-related macular degeneration and diabetic macular edema.
The positive opinion from the Committee covers the use of 8-milligram doses of Eylea, which can now be given at extended treatment intervals of up to every four months after three initial monthly doses. Currently, Eylea is approved in Europe in a 2-milligram dose every eight weeks.
Bayer, in collaboration with Regeneron Pharmaceuticals, has developed Eylea. While Regeneron holds exclusive rights to the drug in the United States, Bayer has been granted exclusive marketing rights outside of the U.S. The two companies equally share the profits from sales of the drug in the U.S.
The European Commission is expected to make a decision on the high-dose formulation of Eylea in the coming months. Given their history of generally following the advice of the Committee for Medicinal Products for Human Use, it is likely that the European Commission will approve the high-dose version.
In August, the U.S. Food and Drug Administration already approved the high-dose version of Eylea.