Ph III studies show Bayer and Regeneron VEGF Trap-Eye in wet AMD meets primary endpoints versus Lucentis

German drug major Bayer (BAY: DE) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN) reveal that, in two parallel Phase III studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution), including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The news lifted Bayer’s shares 0.6% to 58.15 euros in early trading this morning.

The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab, which is marketed as Lucentis by Roche but with fellow Swiss major Novartis having rights to the drug outside the USA. Lucentis, partly due to its high cost, has relatively modest sales, which EvaluatePharma forecasts will by around $1.49 billion for Roche and $1.94 billion for Novartis by 2016.

Regulatory filings expected first-half 2011