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December 1, 2013

Bayer seeks Japanese approval for VEGF Trap-Eye for treatment of myopic CNV

Bayer HealthCare has submitted VEGF Trap-Eye (aflibercept solution for injection) for regulatory approval in Japan to treat patients with myopic choroidal neovascularization (myopic CNV), one of the most common causes of eye disease.

Bayer HealthCare has submitted VEGF Trap-Eye (aflibercept solution for injection) for regulatory approval in Japan to treat patients with myopic choroidal neovascularization (myopic CNV), one of the most common causes of eye disease.

In Japan, pathologic myopia and the related myopic CNV is one of the most common causes of blindness.

The regulatory filing is based on data from the Phase III MYRROR study in mCNV, which had its topline results released earlier this year.

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

Kyushu University Department of Ophthalmology, Faculty of Medicine professor and study coordinator Tatsuro Ishibashi said pathologic myopia develops several lesions affecting the back of the eye such as myopic CNV and is suffered by significant number of patients in Japan.

"A treatment option that could not only prevent permanent vision loss but could also improve visual acuity would have great benefits for patients with pathologic myopia," Ishibashi said.

In Europe, the US, Japan, Australia and in many other countries, vascular endothelial growth factor (VEGF) Trap-Eye has been approved under the brand name Eylea to treat patients with neovascular age-related macular degeneration (wet AMD).

Eylea has already been approved in Europe for treating visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), as well as in the US and in selected Asian and Latin American countries for the treatment of macular edema following CRVO.

Under the global development of Eylea, Regeneron has exclusive rights to the drug in the US, while Bayer has exclusive marketing rights outside the US, where the companies share the profits equally from its sales, except for Japan where Regeneron receives a royalty on net sales.

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