BioSpace has reported on the results of an integrated analysis of two Phase III studies (VIEW 1 and VIEW 2) of aflibercept intravitreal injection in the treatment of neovascular age-related macular degeneration (wet AMD). The 52-week results from the studies have previously been reported; the current data are from a further analysis at 96 weeks.
During the first year of both studies, patients were treated with one of three different dosing regimens of aflibercept (0.5mg every four weeks; 2mg every four weeks; or 2mg every eight weeks, following three initial monthly injections), or ranibizumab 0.5mg every four weeks. [Aflibercept has recently been approved by the US for this indication at a dose of 2mg every eight weeks; it has not yet been approved in the EU]. In the second year, patients were treated with the same dose per injection as in the first year, with retreatment when required (at least every 12 weeks; requirement was assessed at monthly evaluations). The 96-week analysis was considered exploratory.
In an integrated analysis of both studies, the visual acuity gain from baseline at week 96 was 7.6 letters in the 2mg every eight week aflibercept group (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 at week 96 in the ranibizumab group 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.
Further results from year two of the studies will be presented at upcoming medical conferences.