1. In both trials, faricimab was found to be non-inferior to aflibercept in improving visual acuity in neovascular age-related macular degeneration.
2. The number of ocular adverse events was not significantly different between faricimab and aflibercept.
Level of evidence assessment: 1 (Excellent)
Summary of the study: Neovascular age-related macular degeneration (nAMD) affects more than 196 million people worldwide. Current management uses anti-Vascular Endothelial Growth Factor (VEGF) intravitreal therapies. A proposed new intraocular injection therapy, faricimab, targets both VEGF and Ang-2, which are implicated in the pathogenesis of nAMD. The safety and efficacy of faricimab have already been evaluated in a phase 2 trial. This study combined the results of two identically designed randomized controlled trials of faricimab versus aflibercept. The primary endpoint of the study was improvement in visual acuity measured by best corrected visual acuity (BCVA) at 40, 44 and 48 weeks. Accordingly, faricimab was found to be non-inferior to aflibercept in improving BCVA. Adverse events were comparable between the two drugs. Faricimab has the added benefit of being given every 16 weeks versus every 8 weeks for aflibercept. This study was unfortunately affected by the COVID-19 pandemic which impacted data collection. Nevertheless, faricimab was found to be a non-inferior treatment to aflibercept with potentially less clinical burden and prolonged duration of effect.
Click to read the study in The Lancet
Relevant Reading: Ranibizumab for Neovascular Age-Related Macular Degeneration
In depth [randomized controlled trial]: This study analyzed the results of two Phase 3 randomized controlled trials (TENAYA and LUCERNE) evaluating faricimab versus aflibercept. Both trials were identical in design and included treatment-naïve patients aged 50 or older. If participants had disease in both eyes, the eye with the worst visual acuity was used as the study eye. Participants were randomized 1:1 to receive either faricimab every 16 weeks or aflibercept every 8 weeks with dummy doses given to the aflibercept group to preserve masking. The treatment was given for a total of 48 weeks. Follow-up was every 4 weeks and the primary endpoint was best corrected visual acuity (BCVA) at weeks 40, 44, and 48. TENAYA (n=671) and LUCERNE (n=658) had a mean age 74.8 to 76.7 years for randomized participants. For the primary endpoint, both trials demonstrated that faricimab was non-inferior to aflibercept on the primary endpoint of mean change in BCVA. The treatment difference between faricimab and aflibercept for BCVA changes in TENAYA was 0.7 letters [95% CI -1.1 to 2.5] and in LUCERNE was 0.0 letters [-1.7 to 1.8]. Adverse events were comparable between the two drugs in both trials.
Picture: PD
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