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YOSEMITE and RHINE data further supports the novel agent for diabetic macular edema. A study investigators explains the impact of the new findings.
New phase 3 data from the pivotal YOSEMITE and RHINE trials show that doses of investigative ophthalmic therapy faricimab up to every 16 weeks was associated with significant improvements in best corrected visual acuity (BCVA) at 1 year versus anti-VEGF therapy aflibercept (EYLEA).
The newest data from the trial support the potential indicated use of faricimab in adults with diabetic macular edema (DME), one of the leading causes of blindness in the US, while showing the benefit of treating patients with DME via the drug’s unique pathways.
While standard-care DME treatments, anti-VEGF therapy delivered via intravitreal injections (IVI), provide significant benefits in visual acuity, clinicians have frequently expressed desire to achieve benefit with lesser regimented therapies; IVI is associated with worse quality of life, heightened anxiety, and less treatment in patients with chronic retina disease.
Not only does faricimab deviate from standard anti-VEGF therapies by showing long-term efficacy with 1 injection every 16 weeks, it does so by targeting the angiopoietin-2 and VEGF-A pathways.
In an interview with HCPLive regarding the newest YOSEMITE and RHINE data, study investigator Charles C. Wykoff, MD, Chairman of the Clinical Research and Trials Committee at the Retina Consultants of America, discussed the impact of the new findings for patients with DME.
Most notably, the observed “treatment flexibility” afforded by faricimab and observed through 2 different arms provides clinicians a new mean of prescribing strategy for DME.
“The reason this trial is important is because it gives an indication of the true durability, potentially, in the real world,” Wykoff said. “That’s why it was exciting when we saw over 50% of patients are achieving every 16 weeks dosing, and more than 75% are achieving every 8-12 weeks dosing.”
Wykoff also discussed the anatomical outcomes associated with faricimab treatment in patients with DME—the “crux” of the therapy’s contribution to the field—as well as its benefit on metrics of disease activity, including retina fluid.
The study, “Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials,” was published online in The Lancet.