Genentech, a member of the Roche Group, has received FDA approval for Vabysmo (faricimab-svoa) to treat macular edema following retinal vein occlusion (RVO).
Give me a rundown on this drug.
Vabysmo [va-bis-mo] is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for specific retinal diseases (more on that in a moment) and administered via intravitreal injection.
Of note, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new, leaky blood vessels to form and increase inflammation.
Hold up … wasn’t Vabysmo already approved?
Yes, but not for RVO. In February 2022, the drug was previously approved as the first bispecific antibody for ophthalmic use in the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
See here for our coverage.
Also of interest: Vabysmo is currently approved in 80+ countries.
What’s the recommended dosage?
Per the drug’s prescribing information for RVO, a 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.
Click here for wet AMD and DME dosages.
What if more than one eye requires treatment?
As each syringe is meant for treatment of just one eye, a new syringe should be used before administering another dosage of Vabysmo into the other eye.
And afterward?
Patients should be monitored immediately following an injection for any signs of elevated intraocular pressure (IOP).
Additionally, patients are advised to report any suggestive symptoms of endophthalmitis or retinal detachment, such as:
- Vision loss
- Eye pain
- Redness of the eye
- Photophobia
- Vision blurring
Gotcha. Didn’t Genentech just release new clinical data on it?
Indeed they did! Earlier this month, in fact.
Positive, topline, long-term data was reported from two phase 3 trials—BALATON (NCT04740905) and COMINO (NCT04740931)—assessing Vabysmo’s safety and efficacy for macular edema due to branch and central vein occlusion (BRVO and CRVO, respectively) from 24 weeks to 72 weeks.
See here for details on dosings, primary endpoints, and timetables.
Give me the gist of the results.
In a comparison of Vabysmo versus aflibercept injections, non-inferior visual acuity gains were observed for Vabysmo, while average vision gains from baseline were comparable between both Vabysmo and aflibercept.
Any adverse events to know about?
Per Genentech, the most common reaction was conjunctival hemorrhage (occuring in 3% of patients from both studies).
Additionally, the company noted rare post-approval cases of retinal vasculitis and/or RVO in the presence of intraocular inflammation.
Significance?
With this approval, Vabysmo is officially indicated for three retinal diseases with the potential for extended dosing intervals.
Lastly … when will it be available?
No official word yet, although eyecare professionals can click here to learn about prescribing for their patients.