Genentech, a member of the Roche Group, has been granted FDA approval for VABYSMO (faricimab-svoa) Prefilled Syringe (PFS), intended for use in the treatment of three potentially blinding retinal diseases.
First: Give me the rundown on VABYSMO.
Pronounced VA-BIS-MO, the therapeutic is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor administered via intravitreal injection.
Note: Ang-2 and VEGF-A are two disease pathways believed to play a role in vision loss by destabilizing blood vessels, possibly causing new, leaky blood vessels to form and increase inflammation.
And its indication?
You mean indication(s)…
VABYSMO was originally FDA approved in February 2022 as the first bispecific antibody for ophthalmic use in two retinal diseases:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
Then, in October 2023, the drug was approved for treating macular edema following retinal vein occlusion (RVO).
What are the recommended dosages for these diseases?
Per the drug’s prescribing information:
- For wet AMD and DME
- 6 mg (0.05 mL of 120 mg/mL solution) administered via intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first four doses
- This is followed by:
- Optical coherence tomography (OCT) and visual acuity evaluations 8 and 12 weeks later to determine whether to intravitreally administer a 6 mg dose on one of the following three regimens:
- Weeks 28 and 44
- Weeks 24, 36 and 48
- Weeks 20, 28, 36 and 44
- Optical coherence tomography (OCT) and visual acuity evaluations 8 and 12 weeks later to determine whether to intravitreally administer a 6 mg dose on one of the following three regimens:
- This is followed by:
- 6 mg (0.05 mL of 120 mg/mL solution) administered via intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first four doses
- For RVO
- 6 mg (0.05 mL of 120 mg/mL) dose of VABYSMO should be intravitreally administered every 4 weeks—translating to an estimated 28 ± 7 days (monthly) for 6 months—into a single eye in a clinical setting.
Alrighty, now what is this latest FDA approval for, exactly?
This is for VABYSMO 6.0 mg single-dose PFS (note this new addition, as the previous were simply for the solution on its own).
Genentech noted that it delivers the exact same medicine as the already available VABYSMO vials, just in an alternative, ready-to-use format.
Important to note: The original VABYSMO 6.0 mg vial will continue to be available (plus is already approved in 95+ countries [for wet AMD and DME] across the globe and in several countries for RVO.
And the indications for this?
Basically the exact three indications VABYSMO was previously approved for:
- Wet AMD
- DME
- Macular edema following RVO
So why create a PFS version?
It all comes down to ease of use, according to Genentech Chief Medical Officer Levi Garraway, MD, PhD.
“This new offering should make it even simpler (for retina specialists) to administer, thereby enhancing the treatment experience for both physicians and patients,” stated Dr. Garraway, also head of Global Product Development.
Gotcha. And when can we expect this to be on the market?
Per Genentech, VABYSMO PFS “will become available to U.S. retina specialists and their patients in the coming months.”
As always, stay tuned!