NOTE, original article name: Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular edema (YOSEMITE and RHINE): Two randomized, double-masked, phase 3 trials

With the aim to lower treatment burden and optimize patient outcomes in diabetic macular edema, researchers herein assessed 1-year outcomes from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.

• In YOSEMITE and RHINE (randomized, double-masked, non-inferiority trials), 940 patients and 951 adults with vision loss due to center-involving diabetic macular edema were enrolled, respectively.

• The 1,891 patients were randomly assigned to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalized treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100.

• Based on disease activity at active dosing visits, PTI dosing intervals were either extended, maintained, or reduced (every 4 weeks up to every 16 weeks).

• Faricimab with adjustable dosing up to every 16 weeks resulted in robust vision gains and anatomical improvements, establishing the potential for faricimab to extend the durability of treatment for patients with diabetic macular edema.