Aleksandra Rachitskaya, MD: Time to Retinal Fluid Control With Faricimab in DME

Treatment with faricimab was associated with reduced time to retinal fluid control with fewer injections versus aflibercept in patients with diabetic macular edema (DME), according to new findings.

The research, presented at the American Society of Retina Specialists (ASRS) 41st Annual Meeting, suggested early treatment with faricimab, a dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor A (VEGF-A) inhibitor, could improve outcomes beyond anti-VEGF treatment alone.

“I think looking at the data like that, it shows that potentially early treatment with faricimab to stabilize retinal vessels might lead to better outcomes that are beyond just treatment with anti-VEGF agents,” presenting author Aleksandra Rachitskaya, MD, an assistant professor of ophthalmology at Cole Eye Institute, Cleveland Clinic, told HCPLive at ASRS 2023.

The phase 3 YOSEMITE/RHINE randomized controlled trials were designed to assess the efficacy and safety of faricimab in patients with DME. A total of 1891 patients were randomized 1:1:1 to faricimab every 8 weeks (Q8W) after 6 initial Q4W doses, faricimab using a personalized treat-and-extend–based regimen after 4 initial Q4W doses, or aflibercept Q8W after 5 initial Q4W doses through week 96.

Results from YOSEMITE/RHINE showed the robust vision gains and greater central subfield thickness reduction (CST) achieved with faricimab at year 1 were maintained through year 2, with ≥80% of the faricimab treat-and-extend arms on Q16W dosing. For patients on treat-and-extend, more than 80% achieved ≥Q12W dosing. Based on anatomic outcomes at 16 weeks, at 1 year, and at 2 years, the significant reduction of CST with faricimab was considered clinically significant versus aflibercept.

In a posthoc analysis, Rachitskaya and colleagues compared the time to the absence of DME and intraretinal fluid (IRF) between patients treated with faricimab and aflibercept. The absence of DME was predefined as a CST of <325 µm and <280 µm, while the absence of IRF was measured in the central subfield at 1mm.

Upon analysis, more patients achieved an absence of IRF with faricimab versus aflibercept through year 2 of the study, at more than 8 months faster. The time to the 50th percentile for the first absence of IRF was 84 weeks for the aflibercept Q8W arm after a median of 12 injections, compared with 48 weeks for the faricimab Q8W (HR, 1.63; 95% CI, 1.41 - 1.88; P <.0001) and treat-and-extend (HR, 1.67; 95% CI, 1.45 - 1.93; P <.0001) arms, after a respective median of 9 and 7 injections.

In addition, the median time to the first absence of DME (<280 µm CST) was achieved with faricimab 16 weeks faster and with fewer injections compared with aflibercept. The time to the 75th percentile for the first absence of DME was 36 weeks for aflibercept Q8W after a median of 7 injections versus 20 weeks for the faricimab Q8W (HR, 1.37; 95% CI, 1.20 - 1.56; P <.0001) and treat-and-extend (HR, 1.47; 95% CI, 1.29 - 1.68; P <.0001) arms after a median of 5 and 4 injections, respectively.

Rachitskaya noted a pooled posthoc analysis at the end of the study suggested approximately 56% of fairicmab treat-and-extend patients met extension criteria and could potentially have extended to Q20W treatment intervals.

Relevant disclosures for Dr. Rachitskaya include Apellis, Genentech Roche, Novarits, and Regeneron.