Abicipar pegol (previously AGN-150998 or MP0112) is a long-acting potent antagonist of vascular endothelial growth factor (VEGF), which is based on the DARPin® technology. Abicipar pegol was licensed to Allergan from
Further details of the REACH phase 2 study (stage 3):
In stage 3 of the phase 2 study, the safety, efficacy and duration of action of abicipar pegol was investigated compared to the standard of care for wet AMD, ranibizumab. In the double-masked trial, a total of 64 patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol 2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients in the ranibizumab arm of the study received additional doses at 12 and 16 weeks. Patients who were treated with either dose of abicipar pegol received sham injections at 12 and 16 weeks. Patients in all arms of the study were well matched for demographics and baseline characteristics.
The analysis of the topline data showed that after 16 weeks, mean visual acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg, 6.3 letters for abicipar pegol 1mg, and 5.3 letters for ranibizumab. After 20 weeks (12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection), mean visual acuity improvement from baseline was 9.0 letters for abicipar pegol 2mg, 7.1 letters for abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition, Optical Coherence Tomography (OCT) data was supportive of the visual acuity data. Although the study was not powered to show statistically significant differences between treatment groups, these data suggest that the DARPin at the 2 mg dose is at least as effective as monthly ranibizumab, with a longer duration of action of the DARPin.
There were no serious adverse events reported in any study group. Two patients in the abicipar pegol 2mg arm and three patients in the abicipar pegol 1mg group experienced ocular inflammation adverse events.
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