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news.Regeneron Pharmaceuticals and Bayer HealthCare have said that their two Phase 3 studies with VEGF Trap-Eye in wet age-related macular degeneration met the primary endpoint compared to the current standard of care, Ranibizumab dosed every month.
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Regeneron Pharma and Bayer said that the primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to Ranibizumab.
In the North American VIEW 1 study, 96% of patients receiving VEGF Trap-Eye 0.5mg monthly, 95% of patients receiving VEGF Trap-Eye 2mg monthly, and 95% of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision compared to 94% of patients receiving Ranibizumab 0.5mg dosed every month.
In the international VIEW 2 study, 96% of patients receiving VEGF Trap-Eye 0.5mg monthly, 96% of patients receiving VEGF Trap-Eye 2mg monthly, and 96% of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision compared to 94% of patients receiving Ranibizumab 0.5mg dosed every month.
In the VIEW 1 study, patients receiving VEGF Trap-Eye 2mg monthly achieved greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint), compared to Ranibizumab 0.5mg monthly; patients receiving VEGF Trap-Eye 2mg monthly on average gained 10.9 letters, compared to a mean 8.1 letter gain with Ranibizumab 0.5mg dosed every month.
VIEW 2 principal investigator Ursula Schmidt-Erfurth said that the results of the VIEW studies indicate that VEGF Trap-Eye could establish a new treatment paradigm for the management of patients with wet AMD – predictable every-other-month dosing without the need for intervening monitoring or dosing visits.