BAYRY - Bayer files for approval of high/extended dosing regimens of Eylea in EU

• Bayer ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) said on Monday that it submitted an application to the European Medicines Agency (EMA) for the company's and Regeneron Pharmaceuticals' ( NASDAQ: REGN ) aflibercept 8 mg for two eye diseases — neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
• The German conglomerate noted that 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.
• Aflibercept 8 mg showed to be as good as with two extended dosing regimens (every 12 and 16 weeks) compared to the company's and Regeneron's Eylea, (which has a lower dose - aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses.
• "Therefore, extended treatment intervals meet an important patient need. The pivotal trials show unprecedented durability results of aflibercept 8 mg, while securing comparable visual acuity and a similar safety profile compared to Eylea, which is the gold standard," said Christian Rommel, member of the executive committee of Bayer's Pharmaceutical Division and head of Research and Development.

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