Japanese MHLW approves Bayer’s EYLEA® for the Treatment of Myopic Choroidal Neovascularization

Bayer HealthCare has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for EYLEA® (aflibercept solution for injection) for the treatment of myopic choroidal neovascularization (myopic CNV). Pathologic myopia and the associated myopic CNV is the second most common cause of blindness, in Japan.

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, commented, “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. 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.”

The approval is based on positive data from the Phase 3 MYRROR study in myopic CNV. The topline results, where patients receiving EYLEA had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2 letters in patients receiving sham injections ( p<0.0001), were announced at the American Academy of Ophthalmology Congress in New Orleans.

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 licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

Press Release from Bayer: http://www.news.bayer.com/baynews/baynews.nsf/id/Bayer-Receives-Approval-for-EYLEA-for-the-Treatment-of-Myopic-Choroidal-Neovascularization-in-Japan?OpenDocument&sessionID=1411395162

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Related Topics and Keywords

Bayer, Eylea, Japan, Myopic Choroidal Neovascularization, Myopic CNV