Bayer announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a high-dose formulation of the renowned eye drug Eylea for the treatment of wet age-related macular degeneration and diabetic macular edema.
The positive opinion from CHMP supports 8-milligram doses of Eylea, administered at extended intervals of up to every four months after three initial monthly doses. This development marks a significant advancement in the treatment options for these major retinal eye diseases.
Developed in collaboration with Regeneron Pharmaceuticals, Eylea is currently approved in Europe in a 2-milligram dose every eight weeks. The endorsement of the higher-dose version by CHMP opens the door for a more efficient and patient-friendly treatment regimen.
The European Commission is expected to make a decision in the coming months, following its tendency to align with CHMP recommendations. Notably, while Regeneron retains exclusive rights to Eylea in the U.S., Bayer holds exclusive marketing rights outside the U.S., with profits from international sales shared equally between the two companies.
The FDA had previously approved the high-dose version of Eylea in August, reinforcing its efficacy and safety.