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EFFICACY, DURABILITY, AND SAFETY OF FARICIMAB IN DIABETIC MACULAR EDEMA (DME): 1-YEAR RESULTS FROM THE PHASE 3 YOSEMITE AND RHINE TRIALS
Abstract
Background and Aims
DME is a serious, vision-threatening complication of diabetic retinopathy. Intravitreal anti-VEGF therapy is the standard of care for DME; however, optimal vision outcomes often require frequent injections that are burdensome for patients, caregivers, and health care systems. Dual inhibition of VEGF-A and angiopoietin-2 may promote vascular stability and durable efficacy beyond anti-VEGF therapies. YOSEMITE (NCT03622580) and RHINE (NCT03622593) evaluated dual VEGF-A/angiopoietin-2 inhibition with faricimab, the first bispecific antibody designed for intraocular use.
Methods
Patients with DME were randomized 1:1:1 to faricimab every 8 weeks (Q8W), faricimab per personalized treatment interval (PTI), or aflibercept Q8W. Dosing intervals in the PTI arms were adjusted (Q4W up to Q16W) based on prespecified vision and anatomic criteria. The primary endpoint was mean best-corrected visual acuity change at 1 year, averaged over weeks 48, 52, and 56. Other efficacy and safety endpoints were assessed Q4W through week 100.
Results
In total, 1891 patients were enrolled in YOSEMITE (N = 940) and RHINE (N = 951). Both trials met their primary endpoint: mean 1-year vision gains with faricimab Q8W or PTI were noninferior to aflibercept Q8W. Anatomic outcomes (including change in central subfield thickness, absence of DME, and absence of intraretinal fluid over time) consistently favored faricimab over aflibercept. At week 52, > 50% and > 70% of the faricimab PTI arms achieved Q16W and ≥ Q12W dosing, respectively. Faricimab was well tolerated, with no new safety signals identified.
Conclusions
At 1 year, faricimab Q8W or PTI offered durable vision gains and anatomic improvements with up to Q16W dosing.