Extended dosing with faricimab = greater fluid control compared with aflibercept for DME

In two trials, treat-and-extend dosing with faricimab achieved good visual gains and extended durability over 2 years. Image credit: ©REDPIXEL – stock.adobe.com

Treat-and-extend dosing with faricimab (Vabysmo, Roche/Genentech), as seen in the YOSEMITE/RHINE studies (NCT03622580/NCT03622593, respectively), achieved good visual gains and extended durability over 2 years in patients with diabetic macular oedema (DME) compared with aflibercept (Eylea, Regeneron Pharmaceuticals), according to Jennifer I. Lim, MD, who reported the findings at the Association for Research in Vision and Ophthalmology (ARVO). The 2023 meeting was held in April in New Orleans, Louisiana, US. Dr Lim is the UIC Distinguished Professor of Ophthalmology and the Marion H. Schenk Esq Chair in Ophthalmology for Research of the Aging Eye at the University of Illinois College of Medicine, Chicago.

In the 2 large YOSEMITE/RHINE trials, the personalised treat-and-extend regimen was designed to evaluate the long-term potential of faricimab to reduce the treatment burden for patients with DME while maintaining efficacy.

Patients enrolled in the 2 trials were randomised 1:1:1 to faricimab 6.0 mg treat-and-extend, faricimab 6.0 mg every 8 weeks or aflibercept 2.0 mg every 8 weeks through week 100. Pooled data from the 2 trials included 1891 patients. The primary end point was the change in the mean best-corrected visual acuity averaged over weeks 48, 52, and 56.

Patients randomised to the faricimab treat-and-extend regimen received faricimab every 4 weeks until central subfield thickness (CST) had decreased to below 325 microns at week 12 or later. When that was first achieved, the treat-and-extend interval was extended by 4 weeks or maintained depending upon visual acuity and CST parameters. After that point, treatment intervals could be extended by 4 weeks (maximum every 16 weeks), maintained or decreased by 4 to 8 weeks (minimum every 4 weeks) based upon prespecified changes in CST or the best-corrected visual acuity parameters.

Dosing results

Analysis of the data indicated 62% of the patients in the faricimab treat-and-extend arm achieved every-16-week dosing and 78% achieved every-12-week dosing or longer at week 96, while achieving comparable BCVA gains as aflibercept. During the matched-dosing phase of faricimab and aflibercept, greater anatomic benefits were seen.Faricimab-treated eyes achieved earlier and sustained fluid control through 2 years compared to results achieved with aflibercept.

Most patients (79%) treated with faricimab who achieved every-12-week dosing at week 52 maintained that level without reduction through week 96. Likewise, most (76%) patients who achieved every-16-week dosing at week 52 maintained that level through week 96. Only 3.9% of patients continued every-4-week dosing throughout the trial.

Investigators concluded faricimab may have the potential to reduce the treatment burden for patients with DME compared with available anti-VEGF therapies. This research also showed faricimab can result in less leakage of the retinal blood vessels despite less frequent dosing than aflibercept, likely a result of faricimab’s mechanism of dual angiotensin 2 and VEGF-A inhibition.

“The better ‘drying effect’ of faricimab (as seen during the matched dosing phase as well as over the 2-year analysis of retinal fluid, including the time to achieve a dry retina) provides rationale for the efficacy and extended durability with dosing interval, up to every 16 weeks, compared to aflibercept dosed every 8 weeks. Faricimab will enable us, as retina specialists, to lower the treatment burden for our patients,” Dr Lim concluded.

Lim is the UIC Distinguished Professor of Ophthalmology, vice chair for Diversity and Inclusion, director of Retina Service, and the Marion H Schenk Esq Chair in Ophthalmology for Research of the Aging Eye at the University of Illinois College of Medicine, Chicago. She is a consultant for Roche/Genentech.