- 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.
For further details see:
Bayer files for approval of high/extended dosing regimens of Eylea in EU