FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss
– Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness –
– Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option –
– Vabysmo PFS will be available for people living with wet AMD, DME and RVO –
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The Vabysmo prefilled syringe, developed by
“We are pleased that the
Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial.
Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.
To date, Vabysmo is approved in more than 95 countries for wet AMD and DME, and in several countries, including the
Visit Vabysmo.com for additional information.
About Vabysmo® (faricimab-svoa)
Vabysmois the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, 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. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.
Vabysmo
Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
Important Safety Information
Contraindications
Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.
Warnings and Precautions
- Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
- Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection.
- Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with Vabysmo reported such an event.
- Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Healthcare providers should discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.
Adverse Reactions
The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 8%). These are not all the possible side effects of Vabysmo.
Pregnancy, Lactation, Females and Males of Reproductive Potential
- Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
- It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.
Patients may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch
. Patients may also report side effects to
Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit https://www.Vabysmo.com .
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