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Based on a planned, interim analysis of a phase II randomized study, Regeneron Pharmaceuticals and Bayer HealthCare said patients with wet age-related macular degeneration (AMD) who received just one dose of their vascular endothelial growth factor (VEGF) drug (Trap-Eye) maintained or improved vision at 12 weeks.
Tarrytown, NY-Regeneron Pharmaceuticals Inc. and Bayer HealthCare AG said patients with wet age-related macular degeneration who received just one dose of their vascular endothelial growth factor (VEGF) drug (Trap-Eye) had maintained or improved vision at 12 weeks.
In a planned, interim analysis of a phase II randomized study, the companies found the compound achieved a statistically significant reduction in retinal thickness after 12 weeks compared with baseline. Mean change from baseline in visual acuity also demonstrated statistically significant improvement.
Even patients who received a single dose, on average, saw a decrease in excess retinal thickness. Treatment with the drug was generally well-tolerated, and no serious adverse events were reported.
Based on these results, the companies plan to initiate phase III trials in the second half of this year.
The compound is a human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental growth factor. It blocks these growth factors to prevent abnormal angiogenesis.
The companies will commercialize the drug jointly outside the United States, and Regeneron will maintain exclusive rights in the United States.