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November 12, 2013

Bayer’s eye drug Eylea wins Canadian approval for wet AMD treatment

German pharmaceutical firm Bayer has secured approval from Health Canada for Eylea (aflibercept, solution for intravitreal injection) to treat patients with neovascular age-related macular degeneration, wet AMD, a sight-threatening eye condition.

By admin-demo

AMD

German pharmaceutical firm Bayer has secured approval from Health Canada for Eylea (aflibercept, solution for intravitreal injection) to treat patients with neovascular age-related macular degeneration, wet AMD, a sight-threatening eye condition.

AMD is a progressive eye disease that affects a person’s central vision has two forms wet and dry, with wet AMD the most severe form of the disease and can cause a sudden loss of vision within weeks.

University of Toronto associate professor of ophthalmology and vision sciences David Wong said: "The dosing of Eylea every two months has the potential to significantly reduce the burden for patients living with this devastating disease by giving them more time to do the things they like to do."

With the approval of Eylea in Canada, the company said that patients with wet AMD will have more treatment options to help them continue to live fulfilling lives.

The approval is based on two Phase III clinical trial (VIEW 1 and VIEW 2) results, which showed that aflibercept injection dosed every eight weeks, following three initial monthly injections, was non-inferior to ranibizumab injection dosed every four weeks.

"The dosing of Eylea every two months has the potential to significantly reduce the burden for patients living with this devastating disease by giving them more time to do the things they like to do."

Results are measured by the primary endpoint of proportion of subjects who maintained vision at week 52 and the most common adverse reactions reported in patients receiving aflibercept injection were conjunctival haemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

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Bayer has already initiated efforts to gain early and rapid reimbursement for Eylea in order to proceed with its scheduled launch in January 2014.

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body and its major role is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs in a healthy organism.

Also called VEGF Trap-Eye, Eylea is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.

By acting as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), VEGF Trap-Eye can inhibit the binding and activation of their cognate VEGF receptors.

The drug has already been approved in the US, Europe, Japan, Australia, and many other countries for use in wet AMD and in the US, Europe, and several countries in South America for the treatment of macular edema following central retinal vein occlusion (CRVO).


Image: Intermediate age-related macular degeneration. Photo: courtesy of Dcirovic.

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