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Bayer moves closer to another Eylea filing after Regeneron raises sales projections

 
• By Sukaina Virji

Top-line results have been presented of the eye drug Eylea (aflibercept; also known as VEGF Trap-Eye) after one year of treatment in the Phase III GALILEO study in patients with macular oedema due to central retinal vein occlusion (CRVO). Based on the results of this study and one other, Regeneron Pharmaceuticals, Eylea's originator, has submitted a supplemental Biologics License Application (sBLA) in the US for the CRVO indication and has been granted an FDA action date of 23 September 2012. The latest data confirm the primary endpoint results that were seen after 24 weeks from two pivotal trials, GALILEO and COPERNICUS. The results are also in line with previously reported one-year results from the COPERNICUS study.

Top-line results have been presented of the eye drug Eylea (aflibercept; also known as VEGF Trap-Eye) after one year of treatment in the Phase III GALILEO study in patients with macular oedema due to central retinal vein occlusion (CRVO). Based on the results of this study and one other, Regeneron Pharmaceuticals, Eylea's originator, has submitted a supplemental Biologics License Application (sBLA) in the US for the CRVO indication and has been granted an FDA action date of 23 September 2012. The latest data confirm the primary endpoint results that were seen after 24 weeks from two pivotal trials, GALILEO and COPERNICUS. The results are also in line with previously reported one-year results from the COPERNICUS study.

Bayer said it plans to file a marketing application with regulatory authorities for the CRVO indication in Europe in the second half of 2012.

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