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Two Year Results Of Phase 3 Studies With EYLEA™ (aflibercept) Injection In Wet AMD Show Sustained Improvement In Visual Acuity

The overall fewer average number of injections in the second year in the EYLEA 2mg every eight week group compared to the ranibizumab group (4.2 versus 4.7) was driven by the fact that fewer patients needed more intense therapy in the EYLEA 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 EYLEA 2mg every eight week 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 EYLEA 2mg every eight week group required an average of 1.4 fewer injections in the second year compared to the ranibizumab group (6.6 versus 8.0).  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 EYLEA 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 (greater than 10% of patients for the overall study population) 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 (greater than 1% of patients for the overall study population) 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% of patients for ranibizumab and 3.3% of patients in the combined EYLEA groups.

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