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

Current and Novel Therapeutic Approaches for Treatment of Diabetic Macular Edema

“…The one-year results for faricimab showed, on average, VA gains of 11.6 (97.52% CI 10.3 to 12.9) and 10.7 (97.52% CI 9.4 to 12.0) letters in the PTI and every other month arms, respectively, and an average gain of 10.9 letters in the aflibercept arm in the YOSEMITE study (Wykoff et al, 2022 [ 154 ]). In the RHINE study, results were similar, showing mean VA gains of 10.8 (97.52% CI 9.6 to 12.0) and 11.8 (97.52% CI 10.6 to 13.0) letters in the PTI and every other month arms, respectively, for faricimab, and an average gain of 10.3 (97.52% CI 9.1 to 11.4) letters in the aflibercept arm [ 155 ]. The results showed that more than 70% of patients on the faricimab PTI regimen were able to go ≥3 months between each treatment interval and treatment was well-tolerated in both clinical trials [ 155 ].…”

“…In the RHINE study, results were similar, showing mean VA gains of 10.8 (97.52% CI 9.6 to 12.0) and 11.8 (97.52% CI 10.6 to 13.0) letters in the PTI and every other month arms, respectively, for faricimab, and an average gain of 10.3 (97.52% CI 9.1 to 11.4) letters in the aflibercept arm [ 155 ]. The results showed that more than 70% of patients on the faricimab PTI regimen were able to go ≥3 months between each treatment interval and treatment was well-tolerated in both clinical trials [ 155 ]. The study is currently following participants and will release year-2 data when available.…”

Review of Intraocular Inflammation After Antivascular Endothelial Growth Factor Agents

“…52 No patients in either trials had retinal vasculitis or arterial occlusive events. 52 Finally, in the phase III TENAYA and LUCERINE trials for exudative AMD, the faricimab every 16 weeks treatment group had a rate of IOI at 2% compared with 1% for aflibercept in TENAYA, and a rate of 2% in both faricimab and aflibercept groups for the LUCERINE trial 53 ; no retinal vasculitis events or arterial occlusive events were reported in both trials. 53 In January, the FDA approved faricimab in treating both exudative AMD and diabetic macular edema.…”

“…In the phase II AVENUE trial for treatment of AMD, there were a total of 5 cases of 131 patients receiving faricimab in all treatment arms (3.8%) developing IOI 51. In the phase III trials YOSEMITE and RHINE comparing faricimab versus aflibercept in treating diabetic macular edema, YOSEMITE demonstrated that faricimab every 8 weeks had IOI at 2%, faricimab with personalized treatment intervals had a rate of IOI at 2%, whereas aflibercept had a rate of 1%; similarly in RHINE, both faricimab groups had a rate of IOI at 1%, and aflibercept <1% 52. No patients in either trials had retinal vasculitis or arterial occlusive events 52.…”

“…In the phase III trials YOSEMITE and RHINE comparing faricimab versus aflibercept in treating diabetic macular edema, YOSEMITE demonstrated that faricimab every 8 weeks had IOI at 2%, faricimab with personalized treatment intervals had a rate of IOI at 2%, whereas aflibercept had a rate of 1%; similarly in RHINE, both faricimab groups had a rate of IOI at 1%, and aflibercept <1% 52. No patients in either trials had retinal vasculitis or arterial occlusive events 52. Finally, in the phase III TENAYA and LUCERINE trials for exudative AMD, the faricimab every 16 weeks treatment group had a rate of IOI at 2% compared with 1% for aflibercept in TENAYA, and a rate of 2% in both faricimab and aflibercept groups for the LUCERINE trial53; no retinal vasculitis events or arterial occlusive events were reported in both trials 53.…”