Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK) announced that top-line results with VEGF Trap-Eye after one year of treatment in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion or CRVO confirm the primary endpoint results that were seen after 24 weeks from the two pivotal trials, GALILEO and COPERNICUS. The results are in line with earlier reported one-year results from the COPERNICUS study.
Based on the study results, Regeneron (REGN) has already submitted a supplemental Biologics License Application or sBLA in the U.S. and has been granted a FDA action date of September 23, 2012. Bayer HealthCare intends to file a marketing application with regulatory authorities in Europe in the 2012 second half. Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye.
The one-year GALILEO results demonstrated that the proportion of subjects that gained at least 15 letters of vision from baseline to week 52 was 60.2% of patients receiving VEGF Trap-Eye, versus 32.4% of patients receiving sham injections. On the other hand, the one-year COPERNICUS results showed that 55.3% of patients receiving VEGF Trap-Eye dosed monthly for 24 weeks, then on an as-needed basis over the next 28 weeks, gained at least 15 letters on an eye chart compared to 30.1% of patients who received sham injections for the first 24 weeks followed by VEGF Trap-Eye PRN from week 24 to week 52.
Also, the company added that the encouraging results of GALILEO and COPERNICUS for patients with central retinal vein occlusion show a durable improvement in visual acuity after one year of treatment with VEGF Trap-Eye. These data are being presented at the World Ophthalmology Congress in Abu Dhabi today.
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