pharmafileOctober 31, 2018
Tag: Roche , RG7716 , Genentech's Lucentis
In the study, patients were given faricimab in one of two extended dosing regimens – 6mg every 12 or 16 weeks – compared to 0.5mg of ranibizumab (Genentech's Lucentis) every four weeks, with patients in the 16-week group switched to 12-week dosing if they were found to have active disease.
After 24 weeks of treatment, 65% of patients taking faricimab were shown to have no active disease, while initial vision gains were maintained through the full 52 weeks of the study in both dosing regimens, according to the Best Corrected Visual Acuity (BCVA) scale.
Specifically, patients in the 16-week group saw an average improvement of 11.4 letters from baseline, compared to 10.1 letters in the 12-week group; those taking ranibizumab experienced an average improvement of 9.6 letters.
However, all three groups were found to be comparable with regards to the proportion of patients who saw an improvement of more than 15 letters or avoided a loss of more than 15, as well as reduction in central retina thickness.
"Because current anti-VEGF monotherapies for neovascular AMD are burdensome, requiring frequent clinic visits for eye injections, some people are under-treated and experience subsequent declining vision over time," said Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. "The STAIRWAY data show the potential of faricimab to allow fewer injections while achieving and sustaining the same visual gains seen with a current standard of care. Based on these data, we will be initiating a global phase III programme for faricimab in neovascular AMD."
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