Faricimab Data for Diabetic Patients With AMD

Arshad Khanani, MD: Looking at patients with diabetic macular edema, the BOULEVARD study, which was a phase 2 study, showed the efficacy of faricimab compared to ranibizumab. The YOSEMITE and RHINE trials are phase 3 global trials that were designed to look at the safety and efficacy of faricimab compared to aflibercept. The comparator here was aflibercept because it’s a better drying agent in patients with diabetic macular edema. In the YOSEMITE and RHINE studies, patients were either treated with 6 loading doses of faricimab and then treated every 8 weeks, or they received 4 loading doses of faricimab and then went into this PTI, or personalized treatment interval, where they got treatment based on their anatomic as well as visual acuity response. As I said, this was compared to patients treated with aflibercept as part of the label, which was 5 floating doses and then every 8-week treatment. In terms of the top line data, the studies met the primary end point of noninferiority of faricimab compared with aflibercept, but I think for patients with diabetic macular edema, we have to look at some other secondary outcomes. Of course, just like patients with neovascular AMD [age-related macular degeneration], these patients have a high treatment burden, they don’t like to come into clinic, they have commercial insurances, they have to take a day off from work, and it’s a working population, so the treatment burden is really high. But the good news is that looking at the durability of faricimab in the PTI arm, over 70% of patients were on at least q12 week dosing interval at week 52, and half of the patients in the study in the PTI arm went into q16 weeks. So again, you’re significantly reducing the treatment burden for patients with diabetic macular edema by increasing the interval between treatment by using a bispecific antibody that blocks VEGF-A as well as ANG-2. But the other thing which was impressive in this trial is the anatomic improvements in these patients.

When you look at patients that were treated with faricimab, there were more patients who had an absence of intraretinal fluid compared with aflibercept at week 56. There was a higher proportion of patients who were able to get to normal or near normal OCT [optical coherence tomography] compared were aflibercept. I think this is exciting that you can control the disease well by using a bispecific antibody, and there’s a better drying effect that you saw on CST [central subfield thickness] improvement in this trial. The bottom line is faricimab is better in durability compared with aflibercept, better in drying effect compared with aflibercept, and of course safety is again crucial for a new molecule. And the good news is that the safety of faricimab was comparable to aflibercept. We have seen that in the phase 2 trials as well as the neovascular AMD trials, which is good news for patients.

Transcript Edited for Clarity