FDA Approves Faricimab PFS for Leading Causes of Vision Loss

Faricimab-svoa (Vabysmo) in a prefilled syringe (PFS) format was approved¹ by the FDA on July 4 for use in treating patients with age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema after a retinal vein occlusion (RVO). The treatment, developed by Genentech, can now be given in a 6.0 mg single dose of a PFS.

The drug was previously available in vial for doctors to use and will continue to be made available in both formats. Faricimab is the first and only bispecific antibody that can be used for the treatment of the eye. Retinal drying in wet AMD, DME, and RVO as well as quick improvements in vision have been shown to occur in patients using this medication.

Faricimab in a prefilled syringe has been approved by the FDA for use in patients with age-related macular degeneration and diabetic macular edema | Image credit: Calin - stock.adobe.com

Faricimab has previously demonstrated the ability to target and inhibit 2 different signaling pathways that are linked to vision-threatening retinal conditions. This includes angiopoietin-2 and vascular endothelial growth factor-A, both of which are thought to destabilize blood vessels, which leads to vision loss due to the new leaky blood vessels that form and the inflammation that increases in the process. Faricimab is aimed at stabilizing blood vessels in the eyes.

Faricimab was first approved by the FDA in its vial form in 2022.² The 2022 approval was based on the TENAYA and LUCERNE studies that were identical, randomized, multicenter, double-masked phase 3 studies that compared faricimab with aflibercept in 1329 patients who lived with wet AMD. Faricimab was able to meet the primary end point of average change in best-corrected visual acuity (BCVA). The studies both found that faricimab given every 4 months consistently improved BCVA at a rate that was not inferior to aflibercept given every 2 months. The BCVA gains were +5.8 and +6.6 letters for faricimab compared with +5.1 and +6.6 letters in the aflibercept arms in each respective study.

Regarding safety, the most common adverse events included cataract (15%) adverse reactions and conjunctival hemorrhage (8%), though these were not the only possible adverse events reported. Faricimab can cause endophthalmitis or separation of layers of the retina. A temporary increase in pressure in the eye is possible about 60 minutes after the injection. Serious problems related to blood clots, such as a heart attack, have been reported, but they were not common, occurring in 7 of 664 patients with wet AMD, 64 of 1262 patients with DME, and 7 of 641 patients with RVO treated with faricimab. Health care providers should discontinue use of the treatment if their patients develop retinal vasculitis or RVO.

The version of faricimab in the PFS will be made available to retina specialists in the US in the coming months.

“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,” Levi Garraway, MD, PhD, the chief medical officer of Genentech and head of global product development, said in a press release.¹

References

1. FDA approves Genentech’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss. News release. Genentech; July 4, 2024. Accessed July 8, 2024. https://www.gene.com/media/press-releases/15030/2024-07-04/fda-approves-genentechs-vabysmo-prefille
2. Joszt L. FDA approves faricimab to treat wet AMD and DME. AJMC^®. January 31, 2022. Accessed July 8, 2024. https://www.ajmc.com/view/fda-approves-fariximab-to-treat-wet-amd-and-dme