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European Commission approves new indication for Eylea eye drug

The European Commission has approved Eylea (aflibercept) injection for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV), a disease of the retina associated with high degrees of myopia (near-sightedness).

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It is the fifth indication for Eylea, which is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye.

Bayer is co-developing Eylea with Regeneron Pharmaceuticals. A new application for the drug is planned to be launched immediately in Germany.

Eylea was earlier approved for wet age-related macular degeneration and visual impairment due to diabetic macular edema and macular edema secondary to retinal vein occlusion.

The injection is designed to stop the growth of new blood vessels and reduce the ability of fluid to pass via blood vessels in the eye by blocking VEGF-A and placental growth factor (PLGF).

It helps in avoiding VEGF-A and PLGF from interacting with their natural VEGF receptors.

Bayer HealthCare executive committee member and head of global development Joerg Moeller said: "The results of the Phase III study were very encouraging with the majority of patients experiencing a significant two-line improvement in visual acuity on a standard eye chart with aflibercept solution for injection.

"A treatment option that could not only prevent permanent vision loss, but also improve visual acuity could have great benefits for patients with myopic CNV."

Regeneron has exclusive rights to Eylea in the US, while Bayer HealthCare holds the exclusive marketing rights outside the US.

The companies will equally share the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.


Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.