Phase III studies with VEGF Trap-Eye in wet age-related macular degeneration show sustained improvement in visual acuity

Bayer HealthCare and Regeneron Pharmaceuticals announced that in an integrated analysis of two parallel Phase III studies (VIEW 1 and VIEW 2) in patients with the neovascular form of age-related macular degeneration (wet AMD), patients treated with VEGF Trap-Eye showed a sustained improvement in visual acuity at 96 weeks versus baseline.

The 52 week results (primary analyses) from these studies have previously been reported. The VEGF Trap-Eye 2mg every eight weeks regimen was recently approved by the US Food and Drug Administration (FDA).

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 (mg) every four weeks, 2 mg every four weeks, and 2 mg every other month (following three initial monthly injections), 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 2 mg 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 2 mg every two months 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 VEGF Trap-Eye 2 mg 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 2 mg every two months group compared to the ranibizumab group (15.9 percent versus 26.5 percent).

In the 25 percent of patients who required the most intense therapy (the greatest number of injections), patients in the VEGF Trap-Eye 2 mg every two months 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 percent of patients in each group who had the fewest number of injections in the second year, the average number of injections was similar (approximately three 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 (greater 10 percent 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 percent 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 percent for ranibizumab and 3.3 percent in the combined VEGF Trap-Eye groups.