1. In both trials, faricimab was demonstrated to be non-inferior to aflibercept at improving visual acuity in neovascular age-related macular degeneration.
2. Amount of ocular adverse events was not significantly different between faricimab and aflibercept.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Neovascular age-related macular degeneration (nAMD) affects over 196 million people worldwide. The current management utilizes intravitreal anti-vascular endothelial growth factor (VEGF) therapies. A novel proposed intraocular injection therapy, faricimab, targets both VEGF and Ang-2, which are involved in nAMD pathogenesis. Safety and efficacy of faricimab were previously evaluated in a phase 2 trial. This study combined the results of two identically designed randomized controlled phase 3 trials of faricimab versus aflibercept. The primary outcome of the study was improvement in visual acuity measured as best-corrected visual acuity (BCVA) at 40, 44 and 48 weeks. In result, faricimab was demonstrated to be non-inferior to aflibercept in improving BCVA. Adverse events were comparable between the two drugs. Faricimab has the additional benefit of being administered every 16-weeks versus every 8-weeks for aflibercept. This study was unfortunately affected by the COVID-19 pandemic which impacted data collection. Nonetheless, faricimab was demonstrated to be a non-inferior treatment to aflibercept with potentially less clinical burden and extended durability of effect.
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) assessing faricimab compared with aflibercept. Both trials were identical in design and included patients with treatment naïve Neovascular Age-Related Macular Degeneration (nAMD) aged 50 years or older. If participants had disease in both eyes, the eye with worse visual acuity was used as the study eye. Participants were randomized 1:1 to either faricimab every 16 weeks or aflibercept every 8 weeks with sham doses given to the aflibercept group to preserve masking. Treatment was given for a total of 48 weeks. Follow-up occurred every 4 weeks and the primary outcome was measured best-corrected visual acuity (BCVA) at weeks 40, 44 and 48. TENAYA (n=671) and LUCERNE (n=658) had a mean age of 74.8-76.7 years for randomized participants. For the primary endpoint, both trials demonstrated that faricimab was non-inferior to aflibercept regarding the primary outcome of mean change in BCVA. Treatment difference between faricimab versus 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.
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