Arshad Khanani, MD: Four-Year Outcomes of Faricimab for DME in RHONE-X

Four-year data from the RHONE-X extension study demonstrated the continued durability, efficacy, and safety of faricimab (Vabysmo) for the treatment of patients with diabetic macular edema (DME).

These late-breaking data, presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, showed RHONE-X met its primary endpoint, with strong tolerability in the treatment of DME for up to 4 years, and more than 90% of patients experiencing absence of DME.

“This is the first time we have data in a clinical trial setting where we are seeing the benefit of dual inhibition with faricimab in patients who were switched from aflibercept in terms of durability, with approximately 80% of patients on Q12W dosing or greater, highlighting the durability benefit of faricimab,” Arshad Khanani, MD, managing partner, and director of clinical research, at Sierra Eye Associates, told HCPLive.

RHONE-X is the largest long-term extension data set in DME. The two-year extension study evaluated the long-term safety and tolerability of faricimab in 1,474 patients with diabetic macular edema who completed one of the two Phase 3 YOSEMITE or RHINE trials.

In RHONE-X, all participants were treated with faricimab on a personalized treat-and-extend regimen, meaning the time between faricimab treatments could be increased based on retinal fluid levels and visual acuity.

Results from an exploratory analysis revealed patients treated with faricimab sustained vision gains and anatomical improvements, with nearly 80% of the population extending treatment intervals to every three or four months.

“I think if we can decrease the treatment burden for our patients with DME, we will be able to have better retention and less dropout in future trials, as well as in clinical practice,” Khanani told HCPLive.

Patients treated with faricimab also maintained vision improvements and sustained drying of retinal fluid experienced during the initial YOSEMITE and RHINE trials.

In a pre-specified exploratory endpoint, more than 90% of faricimab-treated patients achieved the absence of DME, or central subfield thickness (CST) <325 µm. A reduction in CST, a measure of swelling from fluid in the back of the eye, indicates the potential of faricimab for retinal drying.

“Obviously, we want to make sure that we are looking at safety closely over 4 years and faricimab was well-tolerated without new safety signals, and adverse events were consistent with the Phase 3 YOSEMITE and RHINE trials,” Khanani added.

Disclosures: Relevant disclosures for Khanani include Apellis, Genentech, Iveric Bio, Roche, Regeneron, and others.

References

_{Khanani A. Four-Year Outcomes of Faricimab in DME: First Time Safety and Efficacy Results From the RHONE-X Long-Term Extension Trial. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024.}