Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials

Ophthalmology. 2024 Aug;131(8):950-960. doi: 10.1016/j.ophtha.2024.01.029. Epub 2024 Jan 26.

Abstract

Purpose: To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion.

Design: Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192).

Participants: Patients with treatment-naïve foveal center-involved macular edema resulting from branch (BALATON) or central or hemiretinal (COMINO) RVO.

Methods: Patients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks.

Main outcome measures: Primary end point: change in best-corrected visual acuity (BCVA) from baseline to week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥ 1 doses of study drug.

Results: Enrollment: BALATON, n = 553; COMINO, n = 729. The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON (adjusted mean change, +16.9 letters [95.03% confidence interval (CI), 15.7-18.1 letters] vs. +17.5 letters [95.03% CI, 16.3-18.6 letters]) and COMINO (+16.9 letters [95.03% CI, 15.4-18.3 letters] vs. +17.3 letters [95.03% CI, 15.9-18.8 letters]). Adjusted mean central subfield thickness reductions from the baseline were comparable for faricimab and aflibercept at week 24 in BALATON (-311.4 μm [95.03% CI, -316.4 to -306.4 μm] and -304.4 μm [95.03% CI, -309.3 to -299.4 μm]) and COMINO (-461.6 μm [95.03% CI, -471.4 to -451.9 μm] and -448.8 μm [95.03% CI, -458.6 to -439.0 μm]). A greater proportion of patients in the faricimab versus aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal P = 0.0023) and COMINO (44.4% vs. 30.0%; nominal P = 0.0002). Faricimab was well tolerated, with an acceptable safety profile comparable with aflibercept. The incidence of ocular adverse events was similar between patients receiving faricimab (16.3% [n = 45] and 23.0% [n = 84] in BALATON and COMINO, respectively) and aflibercept (20.4% [n = 56] and 27.7% [n = 100], respectively).

Conclusions: These findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to retinal vein occlusion.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Angiopoietin-2; Faricimab; Macular leakage; Retinal vein occlusion; Vascular endothelial growth factor receptor.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Comparative Study

MeSH terms

  • Aged
  • Angiogenesis Inhibitors* / adverse effects
  • Angiogenesis Inhibitors* / therapeutic use
  • Angiopoietin-2 / antagonists & inhibitors
  • Double-Blind Method
  • Female
  • Humans
  • Intravitreal Injections*
  • Macular Edema* / diagnosis
  • Macular Edema* / drug therapy
  • Macular Edema* / etiology
  • Macular Edema* / physiopathology
  • Male
  • Middle Aged
  • Receptors, Vascular Endothelial Growth Factor* / antagonists & inhibitors
  • Receptors, Vascular Endothelial Growth Factor* / therapeutic use
  • Recombinant Fusion Proteins* / administration & dosage
  • Recombinant Fusion Proteins* / adverse effects
  • Recombinant Fusion Proteins* / therapeutic use
  • Retinal Vein Occlusion* / complications
  • Retinal Vein Occlusion* / diagnosis
  • Retinal Vein Occlusion* / drug therapy
  • Retinal Vein Occlusion* / physiopathology
  • Tomography, Optical Coherence*
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A* / antagonists & inhibitors
  • Visual Acuity* / physiology

Substances

  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • aflibercept
  • Angiogenesis Inhibitors
  • Vascular Endothelial Growth Factor A
  • Angiopoietin-2
  • VEGFA protein, human
  • ANGPT2 protein, human

Associated data

  • ClinicalTrials.gov/NCT04740931