FDA updates Vabysmo label to allow extended RVO macular edema treatment
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
The Food and Drug Administration has approved new labeling for Vabysmo (faricimab-svoa) to allow for extended treatment of macular edema following retinal vein occlusion (RVO). Specifically, the new recommended dose for this indication is 6 mg administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly). This update removes the previous 6-month treatment duration restriction.
Vabysmo was originally approved by the FDA for the treatment of retinal vein occlusion in 2023. In October 2023, it received FDA approval for the treatment of macular edema following RVO based on data from the phase 3 BALATON (NCT04740905) and COMINO (NCT04740931) trials.
Results from these studies demonstrated that faricimab was noninferior to aflibercept based on the mean change in best-corrected visual acuity from baseline. At 24 weeks in BALATON (n = 553), the adjusted mean BCVA change from baseline to week 24 was +16.9 letters with faricimab vs +17.5 letters with aflibercept. In COMINO (n = 729), BCVA gains were +16.9 letters with faricimab vs +17.3 letters with aflibercept.
Anatomic improvements were also comparable, with an adjusted mean central subfield thickness reduction of −311.4 µm vs −304.4 µm in BALATON and −461.6 µm vs −448.8 µm in COMINO (faricimab vs aflibercept, respectively). Safety signals were comparable between arms, with similar ocular adverse event rates across trials: BALATON 16.3% with faricimab vs 20.4% with aflibercept, and COMINO 23.0% vs 27.7%, respectively.
Vabysmo is a bispecific antibody designed to inhibit vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2). Vabysmo is also indicated for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.