The FINANCIAL — Bayer HealthCare and Regeneron Pharmaceuticals, Inc. today announced that in an integrated analysis of two parallel Phase III studies in patients with the neovascular form of age-related macular degeneration, patients treated with VEGF Trap-Eye showed a sustained improvement in visual acuity at 96 weeks versus baseline.
The 52 week results from these studies have previously been reported. The VEGF Trap-Eye 2mg every eight weeks regimen was recently approved by the U.S. Food and Drug Administration.
During the first year of the VIEW 1 and VIEW 2 studies, patients were treated with three different dosing regimens of VEGF Trap-Eye, 0.5 milligram every four weeks, 2mg every four weeks, and 2mg every other month, compared to ranibizumab 0.5mg every four weeks. In the second year of the studies, patients were treated with the same dose per injection as in the first year and were evaluated monthly to determine need for retreatment. Patients were treated at least every 12 weeks. All year two analyses were considered exploratory.
In an integrated analysis of the VIEW 1 and VIEW 2 studies, the visual acuity gain from baseline in the VEGF Trap-Eye 2mg every other month group at week 96 was 7.6 letters compared to 8.4 letters at week 52, with an average of 11.2 injections over two years and 4.2 injections during the second year. The visual acuity gain from baseline in the monthly ranibizumab group at week 96 was 7.9 letters compared to 8.7 letters at week 52, with an average of 16.5 injections over two years and 4.7 injections during the second year. The results of each of the VIEW 1 and VIEW 2 studies were consistent with the integrated analysis.
The overall fewer average number of injections in the second year in the VEGF Trap-Eye 2mg every two months group compared to the ranibizumab group was driven by the fact that fewer patients needed more intense therapy in the VEGF Trap-Eye 2mg every two months group and those patients required fewer injections. The proportion of patients who required frequent injections (six or more) during the second year was lower in the VEGF Trap-Eye 2mg every two months group compared to the ranibizumab group (15.9% versus 26.5%). In the 25% of patients who required the most intense therapy (the greatest number of injections), patients in the VEGF Trap-Eye 2mg every two months group required an average of 1.4 fewer injections in the second year compared to the ranibizumab group. In the 25% of patients in each group who had the fewest number of injections in the second year, the average number of injections was similar (approximately 3 for both groups, corresponding to the protocol-mandated minimum number of injections).
A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease and/or the aging process. The most frequent ocular adverse events were conjunctival hemorrhage, eye pain, retinal hemorrhage, and visual acuity reduced.
The most frequent serious non-ocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD; the most frequently reported events were falls, pneumonia, myocardial infarction and atrial fibrillation. There were no notable differences among the study arms. The incidence of arterial thrombotic events as defined by the “Anti-Platelet Trialists” group criteria was 3.2% for ranibizumab and 3.3% in the combined VEGF Trap-Eye groups.
Further results from year two of the studies will be presented at upcoming medical conferences in 2012.
Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, and other eye diseases and disorders. Bayer submitted an application for marketing authorization in Europe and Japan in wet AMD in the first half of 2011.
Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to EYLEA in the United States.
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