VIDEO: Faricimab approval, other recent developments in diabetic macular edema

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Diabetic macular edema is treated with intravitreal anti-VEGF therapies such as aflibercept 2 mg, ranibizumab 0.3 mg or off-label bevacizumab. But more recently, the exciting developments include the FDA approval of faricimab, the first bispecific that’s being used to treat retinal vascular diseases. Faricimab is an intravitreal injection of an agent that blocks both VEGF-A and angiopoietin-2. The clinical trials for diabetic macular edema looked at dosing regimens of faricimab compared to the standard 2 mg dose of aflibercept, and the results showed that 6 mg of faricimab were noninferior to the standard 2 mg of aflibercept. More importantly, faricimab could be dosed less frequently. And in fact, in the faricimab clinical trials, YOSEMITE and RHINE, a large proportion of faricimab-treated eyes were able to be dosed either every 12 weeks or every 16 weeks through 2 years of the study while maintaining visual acuity benefits. In addition, the FDA also recently approved 8 mg of aflibercept, which is a novel formulation that has four times the molar dose of the standard 2 mg of aflibercept. The clinical trials of aflibercept 8 mg also demonstrated that 8 mg of aflibercept, whether dosed every 12 weeks or every 16 weeks, was noninferior to 2 mg of aflibercept and that patients dosed with 8 mg of aflibercept had excellent visual acuity gains and disease control through 2 years of follow-up. In addition, 8 mg of aflibercept could be dosed less frequently. In fact, 89% of eyes randomized to 8 mg of aflibercept could be dosed every 12 weeks or greater through 2 years of the study, indicating extended durability and better disease control.