FDA approves updated Vabysmo label for macular edema following RVO beyond six months
The FDA approved an updated Vabysmo label for macular edema following retinal vein occlusion beyond six months. The decision extends treatment based on data showing visual acuity gains and central subfield thickness reductions maintained through week 72.
The U.S. Food and Drug Administration has approved Vabysmo (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months. The updated label extends treatment beyond its original prescribing label for macular edema following RVO. RVO affects over a million Americans and often involves long-term intravitreal therapy to address the chronic nature of the disease.
Vabysmo is a prescription medicine given by injection into the eye and is used to treat adults with neovascular (wet) age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion. First approved by the FDA in 2022, Vabysmo is the first bispecific antibody approved for the eye. A pre-filled syringe version of the formulation was later approved in 2024.
Its RVO indication was granted in October 2023 following positive phase 3 data. Vabysmo’s RVO approval was based on positive phase 3 outcomes from the BALATON (NCT04740905) and COMINO (NCT04740931) trials. Key efficacy findings supported use beyond month 6, with visual acuity gains achieved by week 24 and maintained through week 72, while central subfield thickness reductions were also maintained through week 72.
For RVO, a 6 mg (0.05 mL of 120 mg/mL) dose should be administered every 4 weeks, translating to an estimated 28 ± 7 days, for 6 months into a single eye in a clinical setting. The updated dosing is intended to help minimize disruptive treatment switches in patients with RVO who are benefitting from Vabysmo and to provide flexibility to tailor treatment plans and offer seamless, continuous care that helps support longer-term outcomes.