Abstract
Purpose :
Faricimab is a dual angiopoietin-2/vascular endothelial growth factor (VEGF)-A inhibitor and the first bispecific antibody designed for intraocular use. Week 24 results from the phase 3 BALATON/COMINO trials support the efficacy and safety of faricimab for the treatment of macular edema due to retinal vein occlusion (RVO). Week 72 results from these trials will include new information on the long-term efficacy and safety of faricimab in this patient population, as well as the durability of treatment.
Methods :
Anti-VEGF treatment-naïve patients with center-involving macular edema secondary to branch RVO (BALATON [NCT04740905]) or central/hemiretinal RVO (COMINO [NCT04740931]) were enrolled in phase 3, multicenter, randomized trials of faricimab. From day 1 through week 20, patients received 6 monthly intravitreal injections of faricimab 6.0 mg or aflibercept 2.0 mg; the primary endpoint was at week 24. From week 24 through 72, all patients received faricimab 6.0 mg at up to every 16-week (Q16W) intervals per a modified treat-and-extend (T&E)–based dosing regimen. The T&E dosing interval adjustments were based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA).
Results :
553 and 729 patients were enrolled in BALATON and COMINO, respectively. BCVA gains from baseline at week 24 with faricimab were noninferior to aflibercept in BALATON (adjusted mean [95.03% CI] change: +16.9 letters [15.7, 18.1] vs +17.5 letters [16.3, 18.6]) and COMINO (+16.9 letters [15.4, 18.3] vs +17.3 letters [15.9, 18.8]). CST reductions from baseline were comparable across treatment arms. Proportion of patients achieving absence of macular leakage at week 24 for faricimab vs aflibercept: 33.6% vs 21.0% (nominal P = 0.0023) in BALATON; 44.4% vs 30.0% (nominal P = 0.0002) in COMINO. Faricimab was well tolerated through week 24, with a safety profile comparable to aflibercept. Selected week 72 results will be presented at the meeting, including BCVA change and anatomic outcomes, safety (through week 72), and durability (proportion of patients on Q4W, Q8W, Q12W, or Q16W intervals at week 68).
Conclusions :
Following positive 24-week results, 72-week results from BALATON/COMINO will provide important information on the longer-term efficacy and safety of faricimab in patients with RVO, and the durability of faricimab treatment.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.