Bayer plans second eye drug filing in EU on CRVO data

Bayer has unveiled more positive data on VEGF Trap-Eye, and expects to file the Regeneron-partnered drug in Europe later this year for another indication, this time for patients with central retinal vein occlusion.

Top-line data have been presented at the World Ophthalmology Congress in Abu Dhabi on VEGF Trap-Eye (aflibercept) after one year of treatment in the Phase III Galileo study in patients with macular oedema due to CRVO. They confirm the primary endpoint results seen after 24 weeks from Galileo and another study, called Copernicus.

The one-year Galileo results showed 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, compared to 32.4% of patients receiving sham injections. In terms of gain in visual acuity from baseline until week 52, patients receiving VEGF Trap-Eye gained, on average, 16.9 letters of vision compared to a mean gain of 3.8 letters for patients on sham injections.

The results are also in line with previously reported one-year results from Copernicus. In that trial, 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 from week 24 to week 52.

In November last year, the US Food and Drug Administration approved the drug for or the treatment of patients with wet age-related macular degeneration and it is being sold across the Atlantic by Regeneron as Eylea. Regeneron has already submitted a supplemental Biologics License Application in the USA for CRVO and has been granted an action date by the FDA of September 23.

In Europe, Bayer filed VEGF-Trap-Eye for wet AMD in June last year and will submit the drug for CRVO in the second half of this year.