Peter Kaiser, MD:

Hi. My name is Peter Kaiser, and at this year's ARVO, I presented the avacincaptad pegol open-label extension. What this is is in the GATHER2 study, patients were rolled over into an open label extension, where both the patients treated with ACP as well as those treated with sham were rolled over so that all the patients received ACP at monthly intervals for another 18 months. So this was a total of 42 months from baseline to the end of the clinical study.

In the ACP patients who received ACP the entire time, from zero to 24 months, they had about an 18% reduction in growth of the GA, and this increased to about 29% by 42 months. In addition, those patients who converted from sham to ACP in the open label extension, they also had a reduction in GA progression that was very comparable to those patients who received ACP from baseline. Interestingly enough, if you look at the total amount of GA area saved, it was a little over one disc area saved up to 42 months. This is a very large area of retina being saved by the treatment.

And finally, safety is something we would like to know about, because with ACP, we now have 42 months of data with treatment, and the safety was excellent, very consistent with the original GATHER2 two-year safety results. Of note, the IOI rate was 0.1% and all the cases were anterior in nature. There were no cases of retinal occlusive vasculitis or occlusive retinal vasculitis, and there was one case of endophthalmitis that was seen in the patients who went from sham to ACP. So overall, the safety was excellent.

So the bottom line is the open label extension showed that the ACP patients with continued treatment continued to do very well in terms of preventing progression of their geographic atrophy.