The HealthCare segment at Bayer (BAYRY) announced that its blockbuster eye treatment, Eylea, was approved for yet another indication in Japan. The drug was approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of myopic choroidal neovascularization (myopic CNV).
Eylea’s approval in the myopic CNV indication was based on encouraging results from the phase III MYRROR study. The drug is already approved in Japan for the treatment of patients suffering from neovascular age-related macular degeneration (wet AMD) and the treatment of macular edema secondary to central retinal vein occlusion (CRVO).
Earlier in the month, Bayer also submitted the drug in Japan for patients suffering from macular edema secondary to branch retinal vein occlusion (BRVO).
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Bayer has a collaboration agreement with Regeneron Pharmaceuticals Inc (REGN) for the global development of Eylea. Per the terms of the agreement, Regeneron owns the entire U.S. rights pertaining to the eye drug. Bayer is however responsible for marketing Eylea in ex-U.S. markets. The profit earned from the sales of Eylea in those markets is shared equally by the companies. However, in Japan, Regeneron will receive royalties on Eylea’s net sales.
Eylea has been putting up an impressive performance since its launch. The drug is approved in several countries including the U.S. for the wet AMD and CRVO indications. Bayer recorded Eylea sales of €194 million in the second quarter of 2014. We expect the product to continue performing well.
Last week, Bayer announced that it has submitted a Marketing Authorisation Application for Eylea in Japan for the treatment of patients suffering from macular edema secondary to branch retinal vein occlusion (BRVO).
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The Japanese submission for the BRVO indication was based on encouraging results from the phase III VIBRANT study on Eylea. Results from the study revealed that 53% of the patients receiving Eylea (2 mg monthly) gained a minimum of 15 letters (3 lines) in best corrected visual acuity (BCVA) from baseline, compared to 27% of the patients receiving laser, at week 24.
Patients treated with Eylea also showed a 17 letter mean improvement in BCVA from baseline in comparison to a 6.9 letter mean improvement in patients under laser treatment. Moreover, Eylea was well tolerated during the study.
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