Genentech, a member of the Roche Group, has received FDA approval for Vabysmo (faricimab-svoa) to extend treatment of macular edema following retinal vein occlusion (RVO) beyond its original prescribing label.
Let’s start with a refresh on Vabysmo.
It’s definitely been a minute since we talked about the vascular endothelial growth factor (VEGF) therapeutic.
What to know: First approved by the FDA in 2022, VABYSMO is the first bispecific antibody indicated for:
- Neovascular (wet) age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Macular edema following RVO (our topic of interest)
Notably: A pre-filled syringe (PFS) version of the formulation was later approved in 2024.
Its RVO indication also came later, right?
Correct. That indication was granted in October 2023 following the release of positive phase 3 data.
And see here for additional long-term (72-week) results supporting its RVO indication.
So what’s the recommended dosage?
Administered via intravitreal (IVT) injection, Vabysmo’s recommended dosage varies by indication (see its prescribing information [PI] for all three).
For RVO specifically: A 6 mg (0.05 mL of 120 mg/mL) dose should be administered every 4 weeks—translating to an estimated 28 ± 7 days (monthly) for 6 months—into a single eye in a clinical setting.
… and with this updated labeling?
Pertaining exclusively to Vabysmo’s macular edema following RVO indication, the formulation is now approved for treatment beyond 6 months.
And what clinical data supported the extension?
Good question … aside from sharing the updated labeling news, the company didn’t specifically address this.
But remember that 72-week data we referenced earlier? That may have something to do with it.
To refresh: Vabysmo’s RVO approval was based on positive phase 3 outcomes from the BALATON (NCT04740905) and COMINO (NCT04740931) trials.
- The key efficacy findings supported use beyond month 6, with:
- Visual acuity gains achieved by week 24 and maintained through week 72
- Central subfield thickness reductions were also maintained through week 72
Got it. So how will this update impact patients?
The intent is for this label update to “help minimize disruptive treatment switches” in RVO patients already benefiting from the therapeutic.
- This is according to Genentech’s Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development.
Even more so: This will also (ideally) enable more flexible and tailored treatment plans for RVO patients, providing “continuous care” and “long-term outcomes.”