This article is part of Ophthalmology Advisor’s Focus on Retina coverage from the 2021 meeting of the American Academy of Ophthalmology, held in New Orleans from November 12 to 15, 2021. The team at Ophthalmology Advisor will be reporting on a variety of the research presented by the retinal experts at the AAO. Check back for more from the AAO 2021 Meeting.
Faricimab (FAR), a bispecific monoclonal antibody targeting Ang-2/VEGF-A, was comparable to aflibercept (AFL) in the treatment of patients with neovascular AMD (nAMD), according to results presented at the American Academy of Ophthalmology 2021 Annual Meeting, held in New Orleans from November 12-15.
The research was taken from 2 clinical trials — TENAYA (ClinicalTrials.gov Identifier: NCT03823287, N=671) and LUCERNE (ClinicalTrials.gov Identifier: NCT03823300, N=658). Both were randomized, double-masked, active comparator-controlled, 112-week, phase 3 trials. Patients were randomly assigned to receive 6 mg of FAR up to every 16 weeks (q16w), based on disease activity at 20 and 24 weeks, or 2 mg of AFL every 8 weeks.
Investigators reported that average best corrected visual acuity gains from baseline at week 48 with FAR up to q16w (5.8 and 6.6 ETDRS letters in TENAYA and LUCERNE) were similar to AFL q8w (5.1 and 6.6 letters). These numbers were averaged across weeks 40, 44, and 48. The researchers also observed comparable anatomic improvements across all treatment groups. FAR was well tolerated by patients with no reports of vasculitis/occlusive retinitis.
At week 48, 45% of patients in the FAR treatment group were on q16w dosing with 80% on greater than or equal to q12w dosing, demonstrating that FAR treatment has potential for up to q16w fixed-dosing intervals in patients with nAMD.
Singh RP, Heier JS, Holz FG, Silverman D. Faricimab in neovascular AMD: primary results from the phase 3 TENAYA and LUCERNE trials. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA048.