FDA Approves Vabysmo Prefilled Syringe for Key Causes of Vision Loss
Key Insights
The FDA has approved Genentech's Vabysmo prefilled syringe (PFS) for treating wet AMD, DME, and macular edema (search) following RVO, impacting nearly three million people in the U.S.
Vabysmo is the first bispecific antibody for the eye, targeting Ang-2 (search) and VEGF-A (search), offering rapid vision improvement and retinal drying in approved conditions.
The Vabysmo PFS provides the same medicine as the vial form in a ready-to-use format, simplifying administration for retina specialists and enhancing patient experience.
Genentech, a member of the Roche Group, has received FDA approval for its Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of wet (neovascular) age-related macular degeneration (search) (AMD), diabetic macular edema (search) (DME), and macular edema (search) following retinal vein occlusion (search) (RVO). These conditions collectively affect approximately three million individuals in the U.S.
Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, stated, “We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME and RVO, which are some of the leading causes of vision loss. While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”
The Vabysmo PFS delivers the same 6.0 mg dose of faricimab as the currently available Vabysmo vials but in a more convenient, ready-to-use format. The original vial formulation will remain available.
Mechanism of Action
Vabysmo stands out as the first bispecific antibody approved for ophthalmic use. It functions by targeting and inhibiting two signaling pathways critical in several vision-threatening retinal conditions: angiopoietin-2 (Ang-2 (search)) and vascular endothelial growth factor-A (VEGF-A (search)). By neutralizing both Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels, addressing their destabilization, which can lead to the formation of leaky blood vessels and increased inflammation.
Clinical Impact
Vabysmo has demonstrated rapid and robust improvements in vision and retinal drying in patients with wet AMD, DME, and RVO. Retinal drying is a key clinical measure, as swelling caused by excess fluid in the back of the eye is associated with distorted and blurred vision.
Global Reach and Access
To date, Vabysmo has been approved in over 95 countries for the treatment of wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. As of July 2024, more than four million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.
Genentech provides comprehensive services to help patients access Vabysmo, including patient assistance programs through Genentech Access Solutions. Patients can call 833-EYE-GENE or visit http://www.Genentech-Access.com for more information.
Safety Information
Contraindications: Vabysmo is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to faricimab or any of its excipients.
Warnings and Precautions:
- Injections such as Vabysmo can cause endophthalmitis or retinal detachment. Patients should be monitored for symptoms such as increasing eye pain, vision loss, sensitivity to light, or redness.
- Vabysmo may cause a temporary increase in intraocular pressure (IOP) within 60 minutes of injection.
- Thromboembolic events have been reported, although not commonly, in Vabysmo patients. In wet AMD studies, 7 out of 664 patients reported such events in the first year. In DME studies, 64 out of 1,262 patients reported these events up to week 100. In RVO studies, 7 out of 641 patients reported such events during 6 months.
- Retinal vasculitis and/or retinal vascular occlusion, often with intraocular inflammation, have been reported. Treatment should be discontinued in patients who develop these events, and patients should report any vision changes immediately.
Adverse Reactions: The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and conjunctival hemorrhage (8%).
Use in Pregnancy: Women of reproductive potential should use effective contraception during treatment and for 3 months after the last dose due to potential risks to an unborn baby.