BAYRY - Bayer files for approval of high dose Eylea in Japan

Bayer ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) filed an application to Japan's Ministry of Health, Labor, and Welfare (MHLW) seeking approval of a high dose version, 8-mg, of the company's and Regeneron Pharmaceuticals' ( NASDAQ: REGN ) blockbuster drug Eylea (aflibercept) for two eye diseases.

The submission for aflibercept 8-mg is to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The German conglomerate said that aflibercept 8-mg has been developed to increase intervals between injections without compromising vision gains.

"Extended treatment intervals meet an important patient need by significantly reducing the disease burden for patients with exudative retinal diseases. Aflibercept 8 mg has been shown to be highly durable, with comparable visual acuity and safety to the gold standard, Eylea," said Christian Rommel, member of the executive committee of Bayer's Pharmaceutical Division and head of Research and Development.

The filing was backed by data from a phase 3 study, dubbed PULSAR, in nAMD and a phase 2/3 study called PHOTON in DME.

The company noted that in the studies, aflibercept 8-mg showed comparable visual acuity with extended treatment intervals of every 12 and every 16 weeks to Eylea (which has a lower dose - aflibercept 2 mg) dosed every 8 weeks, after initial monthly doses, at week 48.

Bayer has already filed for approval of the higher dose version of the drug in the EU, while Regeneron's application for the therapy is under priority review in the U.S.

Regeneron has exclusive rights to Eylea and aflibercept 8-mg in the U.S. Bayer has licensed exclusive marketing rights outside the U.S. where the companies share profits equally Eylea sales.

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