VEGF Trap maintains gain in visual acuity

Germany's Bayer HealthCare AG and USA-based Regeneron Pharmaceuticals say that their VEGF Trap-Eye dosed on an as-needed dosing schedule maintained the statistically-significant gain in visual acuity achieved after an initial, 12-week, fixed-dosing stage of a Phase II study in neovascular age-related macular degeneration.

This showed that across all doses in the study population, the 6.6 mean letter gain in visual acuity achieved versus baseline at the week 16 evaluation visit, following 12 weeks of fixed dosing, was maintained out to week 32 (a 6.7 mean letter gain versus baseline; p<0.0001) using a dosing frequency determined by the physician's assessment of pre-specified criteria. The decrease in retinal thickness, an anatomical measure of treatment effect achieved with a fixed-dose schedule, was also maintained for all dose groups combined at week 32 (a 137 micron mean decrease vs baseline, p<0.0001). Patients on monthly doses of VEGF Trap-Eye, either 0.5mg or 2.0mg, for 12 weeks followed by PRN dosing thereafter achieved mean improvements in visual acuity of 8.0 (p<0.01 vs baseline) and 10.1 letters (p<0.0001 vs baseline), respectively.