Bayer HealthCare has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Eylea (aflibercept solution for injection) to treat patients with myopic choroidal neovascularization (myopic CNV).
Eylea is a recombinant fusion protein, in which portions of human Vascular Endothelial Growth Factor (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.
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Bayer HealthCare executive committee member and global development head Joerg Moeller said: "Myopic CNV has a poor prognosis and more treatment options are needed to address the urgent medical need for these patients, many of whom are of working age.
"This additional approval for Eylea is great news for patients in Japan suffering from this potentially sight-threatening eye condition."
Approval was based on positive data from the Phase III MYRROR study in myopic CNV.
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The study demonstrated a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared with a loss of two letters in patients receiving sham injections (p<0.0001).
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By GlobalDataBayer HealthCare and Regeneron have partnered on the global development of Eylea.
Under the deal, Regeneron holds exclusive rights for Eylea in the US, while Bayer holds the exclusive marketing rights outside the US.
Eylea has obtained approval in around 80 countries to treat patients with neovascular age-related macular degeneration (wet AMD), while in about 60 countries to treat visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
The drug also secured approval to treat diabetic macular edema (DME) in around 30 countries.
In addition, Bayer has filed application for marketing authorisation in Europe, Japan and the US to treat macular edema secondary to branch retinal vein occlusion (BRVO).
Image: Bayer HealthCare building located in Wedding district of Berlin, Germany. Photo: courtesy of ChristianSchd.
