Bayer HealthCare, a subgroup of German conglomerate Bayer AG (BAYRY.PK,BAYZF.PK), Friday announced that the Ministry of Health, Labour and Welfare in Japan has approved its Eylea or aflibercept injection for treatment of wet age-related macular degeneration or wet AMD in Japan.
Age-related macular degeneration is a leading cause of acquired blindness. In Japan, AMD is the fourth most common cause of acquired blindness, with an increasing number of patients. Macular degeneration is diagnosed as either dry or wet. In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid.
Kemal Malik, member of the Bayer HealthCare executive committee and head of global development said, "The approval of EYLEA in Japan for the treatment of wet AMD is great news for increasing numbers of patients in Japan suffering from this potentially sight threatening eye condition."
Bayer has received approval for Eylea injection for treatment of patients with neovascular wet AMD, at a recommended dose of 2 milligram intravitreal injection per month for three consecutive months. In the maintenance phase, the recommended treatment is usually one intravitreal injection every two months.
According to the company, the approval is based on results of two Phase III clinical studies, which demonstrated that Eylea dosed every other month, following three initial monthly doses, was non-inferior to Lucentis (ranibizumab injection) dosed every four weeks.
In addition, the Phase III trials are currently underway with VEGF Trap-Eye in the treatment of diabetic macular edema and myopic choroidal neovascularization. Myopia is one of the most common eye conditions, which is highly prevalent in Asian countries, including Singapore and Japan.
Eylea was already approved in the U.S., in Macular Edema following Central Retinal Vein Occlusion, or CRVO, and in wet AMD. Bayer said it plans to submit for marketing authorization in CRVO in Europe at the end of this year.
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. (REGN: Quote) are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the U.S.
Bayer HealthCare has exclusive marketing rights outside the U.S., where the companies will share equally the profits from any future sales of Eylea, except for Japan. In Japan, Regeneron will receive a royalty on net sales.
On Frankfurt's Xetra, Bayer shares are currently trading at 67.67 euros, down 1.07 percent, on a volume of 940 thousand shares.
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by RTT Staff Writer
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