USA: A team of researchers led by Charles C Wykoff conducted a study that showed that with flexible dosage up to every 16 weeks, faricimab showed robust vision gains and anatomical improvements. This suggests the potential for faricimab to extend the durability of therapy for individuals with diabetic macular edema. The findings of this study were published in The Lancet, on 24th January 2022.
This study provides 1-year data from two phases 3 studies of faricimab, a new angiopoietin-2, and vascular endothelial growth factor-A bispecific antibody, to minimize treatment burden and improve patient outcomes in diabetic macular edema.
YOSEMITE and RHINE were non-inferiority studies that were randomized, double-masked, and conducted at 353 locations worldwide. Adults with vision loss due to diabetic macular edema were randomly assigned (1:1:1) to receive 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 until week 100. Based on disease activity during active dosing visits, PTI dosage intervals were prolonged, maintained, or decreased (every 4 weeks up to every 16 weeks). The primary outcome was the mean change in best-corrected visual acuity after one year, averaged over weeks 48, 52, and 56. The intention-to-treat population was used for efficacy analysis (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); patients who received at least one dose of study treatment were included in the safety analyses.
The key highlights of this study are as follow:
1. YOSEMITE and RHINE were non-inferiority trials that were randomized and double-masked. In YOSEMITE (n=1532) and RHINE (n=1715), 3247 patients were examined for eligibility.
2. Following exclusions, 940 patients were recruited in YOSEMITE between September 5, 2018, and September 19, 2019, while 951 patients were enrolled in RHINE between October 9, 2018, and September 20, 2019.
3. These 1891 patients were given faricimab every 8 weeks, faricimab PTI every 8 weeks, or aflibercept every 8 weeks at random.
4. Faricimab every 8 weeks achieved non-inferiority for the main outcome (adjusted mean against aflibercept every 8 weeks in YOSEMITE 107 ETDRS letters and faricimab PTI).
5. The occurrence of ocular adverse events was comparable when faricimab was administered every 8 weeks.
Reference:
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. Wykoff, Charles CAaberg, Thomas et al. https://doi.org/10.1016/S0140-6736(22)00018-6