Two-year results from YOSEMITE and RHINE suggest that the positive results of faricimab for DME in year one carried into second year. Dr. Caroline Baumal joins for an in-depth discussion on the findings.
New data on the efficacy, durability, and safety of faricimab suggest its importance as a novel treatment for diabetic macular edema (DME).
Although anti-VEGF monotherapy has defined the last two decades, the treatment burden for patients who need frequent injections may not be sustainable.
In an interview with HCPLive, Caroline Baumal, MD, New England Eye Center, Tufts Medicine, discussed the pivotal phase 3 YOSEMITE and RHINE investigating faricimab for treatment of center-involved DME.
She presented the two-year findings at the 2022 American Academy of Ophthalmology Meeting in Chicago.
"The great news is that the positive results seen at year one continued through year two of the study," Baumal said.
Patients in the fixed treatment arm was given faricimab every 8 weeks with 6 monthly loading doses. The personalized treatment interval (PTI) was a protocol-driven treat or extend.
"It was an optical coherence tomography (OCT) driven protocol with visual acuity inputs to decide whether the treatment interval would be extended or reduced and patients could be treated up to every 16 weeks as the interval between injections," Baumal said.
The comparator was aflibercept given per the label. Baumal noted that the findings reported both faricimab treatment arms gained between 10.4 and 10.8 letters at study endpoint, while aflibercept gained 10.3 letters.
Baumal added that some of the most interesting data came from the anatomic results. Investigators looked at the time to abscence of DME in the 75th percentile of patients.
"That was achieved sooner in both the faricimab every 8 week and the faricimab PTI arm up to every 16 week interval compared to the aflibercept treated eyes," Baumal said. "That was 20 weeks in the faricimab-treated eyes after a mean of 4.2 injections in PTI eyes and 4.8 injections in faricimab Q8W, compared to week 36 after 6.7 in aflibercept treated eyes."
Investigators additionally looked at time to abscence of intraretinal fluid and the number of injections required to reach this marker. Baumal noted it was achieved at week 48 in both faricimab groups, after 7.5 injections in PTI eyes and 8.4 injections in Q8W treatment group. Comparatively, it was achieved at week 84 after a mean of 11.7 injections in the aflibercept group.
"With faricimab, we have another agent to add to our armamentarium of how we treat DME," Baumal said. "The durability results are really promising."
"Efficacy, Durability, and Safety of Faricimab in Diabetic Macular Edema (DME): 2-Year Results From YOSEMITE and RHINE," was presented at AAO 2022.