EU approval for Bayer’s Eylea in diabetic macular oedema

Bayer HealthCare’s Eylea (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular oedema (DMO). The drug is set for an immediate roll-out in Europe, with Germany among the first launch countries.

Eylea is one of Bayer’s strongest performers, alongside anticoagulant Xarelto (Rivaroxaban) and the cancer drugs Stivarga (regorafenib) and Xofigo (radium Ra 223 dichloride injection).

“The approval of Eylea in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DMO,” said Dr Joerg Moeller, of the Bayer HealthCare executive committee and head of global development. “This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions.”

“The results of two phase III studies were very encouraging with the majority of patients with visual impairment due to diabetic macular oedema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection,” said Prof Jean-Francois Korobelnik, principal investigator of the VIVID-DMO trial and chief of ophthalmology, CHU Bordeaux, adding that early diagnosis of DMO was critical, with a high risk of blindness without intensive treatment.

Eylea has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion. Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DMO. In addition, in Japan, Eylea has been submitted for approval for the treatment of choroidal neovascularisation secondary to pathologic myopia (mCNV). A regulatory submission has also been made in Europe and the US for Eylea for the treatment of visual impairment due to macular oedema following branch retinal vein occlusion.

Bayer HealthCare and Regeneron Pharmaceuticals Inc are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the US. Bayer HealthCare has licensed the exclusive marketing rights outside the US, where the companies share the profits from sales of Eylea equally, except for Japan where Regeneron receives a percentage of net sales.

DMO and diabetic retinopathy (DR) are common microvascular complications in people with diabetes. DR affects the blood vessels of the retina. It occurs when fluid leaks into the centre of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.

Visual impairment due to DMO is estimated to affect 3-4 per cent of people with diabetes and is the most frequent cause of blindness in young and middle-aged adults in most developed countries. As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DMO will also grow.

(VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to oedema.

Aflibercept acts as a soluble decoy receptor that binds Vascular Endothelial Growth Factor (VEGF)-A and placental growth factor (PlGF) and can inhibit the binding and activation of their cognate VEGF receptors. Although it triggers formation of healthy new blood vessels, VEGF can also be associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to oedema.

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Bayer submits Eylea for use in BRVO

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