Regeneron and Bayer announce positive results from macular degeneration study

Study results showed that across all dose groups 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 PRN (as-needed) dosing schedule (where dosing frequency was 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 versus baseline, p<0.0001). Patients receiving monthly doses of VEGF Trap-Eye, either 0.5 or 2mg, for 12 weeks followed by PRN dosing thereafter achieved mean improvements in visual acuity of 8 (p<0.01 versus baseline) and 10.1 letters (p<0.0001 versus baseline), respectively, and mean decreases in retinal thickness of 141 (p<0.0001 versus baseline) and 162 microns (p<0.0001 versus baseline) at week 32, respectively. VEGF Trap-Eye was generally safe and well tolerated and there were no drug-related serious adverse events.