At ASRS 2022, John Kitchens, MD, presented, “Personalized Treatment Interval Dosing Dynamics Over 2 Years in the Phase 3 YOSEMITE and RHINE Trials of Faricimab."
Hi, my name is John Kitchens with Retina Associates of Kentucky and Eye Care Partners, here at the 2022 ASRS annual meeting in New York City.
So I talked about the Year 2 data specific to the PTI group, which is a personalized treatment interval group in the Phase 3 Yosemite and Rhine studies. Now, the Yosemite and Rhine studies were studies looking at faricimab, which is the first bi-specific antibody targeting both VEGF and Ang2 in diabetic macular edema.
And when we look at this study, we had three treatment groups. We had the comparator arm, which was aflibercept, utilized monthly for five months, and then every other month. We had a faricimab treatment group, which was every month for six months, and then every other month. But the real interesting group is the faricimab PTI group. And this was, these were patients that were treated with faricimab every month for four months. And then were treated on a treat-and-extend interval, extending out visits every four weeks longer if they were stable.
So what we found in this PTI group—it was so interesting—is that those patients treated with that personalized treatment interval, were able to maintain excellent visual acuities, equivalent to the other two dosing strategies, with far fewer injections.
And what we found that patients could be extended out up to about a fifth of patients in both Yosemite and Rhine right away out to Q 16-week dosing, so they would go for monthly for four visits, then Q 8 weeks for one visit, and Q 12 weeks for one visit, and then out to 16 weeks, and were able to be maintained on that for the entire two years of the study. If patients ended up getting out to Q 12 weeks or Q 16 weeks in the first year, almost 80% of those patients were able to be maintained on that treatment interval.
So if you were someone who could get out to Q 16 weeks within the first year, 80% chance you could stay at that Q 16 weeks for that entire second year, which is absolutely outstanding with no deterioration of visual acuity, and most importantly, no adverse events in regards to occlusive retinal vasculitis, which is something we're all a little bit concerned about now.
So once again, in that PTI treatment group, we're able to extend patients out to Q 12 weeks or Q 16 weeks, up to 80% and 60% of the time, respectively, with great visual acuity and anatomical results. Thanks for watching.