Faricimab shows efficacy, safety and durability in treatment of wet AMD
Results at 48 weeks in the TENAYA and LUCERNE phase 3 trials showed positive outcomes of faricimab for neovascular age-related macular degeneration.
Dosing intervals were between 12 and 16 weeks in 80% of the patients.
“Faricimab is the first bispecific antibody designed for intraocular use. It targets and neutralizes both Ang-2 and VEGF-A in order to stabilize vessels as well as reduce vascular hyperpermeability, inflammation and neovascularization,” Frank G. Holz, MD, PhD, said at the virtual Euretina congress.
The two studies enrolled a total of 1,329 patients across 271 sites worldwide who were randomly assigned to receive either faricimab (Genentech) or aflibercept (Regeneron) intravitreal injections. Response to faricimab was measured at weeks 20 and 24. Based on prespecified central subfield thickness (CST) OCT measurements and best corrected visual acuity criteria, patients with active disease at week 20 received dosing every 8 weeks, those with active disease at week 24 received dosing every 12 weeks, and patients without active disease received dosing every 16 weeks. Aflibercept was administered every 8 weeks, in line with the label.
“At week 48, nearly 80% of the patients in the faricimab arm had achieved a 12- or 16-week treatment interval, and 45% achieved a 16-week interval. The primary endpoint was met, demonstrating noninferior vision gains vs. aflibercept. The initial VA gains were sustained in the majority of patients, including those on extended fixed regimen of faricimab Q12W or Q16W. The VA outcomes were highly consistent between the two studies. Anatomically, on structural OCT assessment, reductions from baseline CST at all time points and at week 48 were meaningful and comparable across both studies,” Holz said.
Adverse events were higher in the faricimab arms but were low in number and resolved. No cases of vasculitis or occlusive retinitis were reported.
“Two-year results are awaited from both trials, and the AVONELLE-X extension study will generate 4-year long-term data,” Holz said.
In the discussion, he advocated a future systematic comparison between faricimab and aflibercept both at extended dosing intervals.
“From the viewpoint of the regulative authority, a comparator needs to be administered according to label, but if the comparator also has the chance to show extended durability, it would be worthwhile making a fair comparison,” he said.
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Holz FG. Efficacy, safety and durability of faricimab in neovascular age-related macular degeneration. Week 48 results from the phase 3 TENAYA and LUCERNE trials. Presented at: Euretina congress; Sept. 9-12, 2021 (virtual meeting).
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