FDA Approves Prefilled Syringe of Faricimab (Vabysmo) for AMD, DME, and RVO

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved a 6.0 mg single-dose prefilled syringe of faricimab (Vabysmo) for use in the treatment of a trio of ophthalmic disorders.

Announced by Genentech on July 04, 2024, the prefilled syringe, which is indicated for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO), is designed to simplify administration and is the first and only syringe with an FDA-approved bispecific antibody to treat retinal conditions.¹

“We are pleased that the US 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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech.¹ “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.”

A bispecific antibody targeting angiopoietin-2 and vascular endothelial growth factor-A pathways, faricimab became the first bispecific antibody approved for use in the eye with its approval for treatment of wet AMD and DME in 2022 based on data from a clinical program comprised of the TENAYA and LUCERNE (AMD) and the YOSEMITE and RHINE DME trials. The agent would go on to receive a third FDA indication with approval for RVO in 2023 based on the BALATON and COMINO studies.^1,2

TENAYA and LUCERNE

TENAYA and LUCERNE were identical, randomized, multicenter, double-masked, phase 3 trials examining use of faricimab relative to aflibercept among patients with wet AMD. The trials included 1329 people living with wet AMD, with 671 enrolled in TENAYA and 658 enrolled in LUCERNE.^3,4

Patients were randomized to faricimab 6 mg administered at intervals of 2, 3, or 4 months, following 4 initial monthly doses, and aflibercept 2 mg administered at fixed 2-month intervals after 3 initial monthly doses. Of note, faricimab dosing intervals were selected based on an objective assessment of disease activity measured by optical coherence tomography and visual acuity evaluations at weeks 20 and 24. The trials had a primary endpoint of mean change in best-corrected visual acuity (BCVA) score from baseline, averaged over weeks 40, 44, and 48.^3,4

At 1 year of the TENAYA and LUCERNE trials, the mean vision gains from baseline at one year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms. In February 2024, 2-year results indicated treat-and-extend faricimab treatment based on disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals.^3,4

YOSEMITE and RHINE

YOSEMITE and RHINE were identical, randomized, multicenter, double-masked, phase 3 trials examining use of faricimab relative to aflibercept among patients with DME. The trials included 1891 people living with DME, with 940 enrolled in YOSEMITE and 951 enrolled in RHINE.^5,6

The trials had 3 treatment arms, with patients randomized to 6.0 mg administered up to every 4 months after 4 initial monthly doses using a treat-and-extend approach, faricimab 6.0 mg administered at 2-month intervals after 6 initial monthly doses, and aflibercept administered at fixed 2-month intervals after 5 initial monthly doses. The trials had a primary endpoint of mean change in BCVA score from baseline at 1 year, averaged over weeks 48, 52, and 56.^5,6

Results of these trials suggested use of faricimab was associated with robust vision gains and anatomical improvements, with adjustable dosing up to every 16 weeks. An analysis of 2-year results from the trial published in December 2023 indicated use was associated with clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability were maintained through year 2, with adjustable dosing up to every 16 weeks.^5,6

BALATON and COMINO

BALATON and COMINO were randomized, multicenter, double-masked, phase 3 trials. The BALATON trial included 553 patients with branch RVO and COMINO included 729 people with central retinal or hemiretinal vein occlusion.^2,7

In the first 20 weeks of the trials, patients were randomized in a 1:1 ratio to monthly faricimab 6.0 mg or aflibercept 2.0 mg for 6 months. For weeks 24 through 72, all patients received faricimab at dosing intervals of up to every 4 months, using a treat-and-extend dosing regimen. The primary endpoint for both studies was the change in best-corrected visual acuity from baseline at 24 weeks.^2,7

The trials met the primary endpoint, with use of faricimab associated with early and sustained improvement in vision in people with branch and central RVO and non-inferior visual acuity gains at 24 weeks relative to aflibercept. In January 2024, long-term results showed nearly 60% of individuals with branch RVO receiving faricimab in BALATON and up to 48% of people with central RVO in COMINO were able to extend their treatment intervals to 3 or 4 months apart.^2,7

References:

1. Genentech. FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss. Genentech: Press Releases | Thursday, Jul 4, 2024. July 4, 2024. Accessed July 5, 2024. https://www.gene.com/media/press-releases/15030/2024-07-04/fda-approves-genentechs-vabysmo-prefille.
2. Campbell P. Faricimab (Vabysmo) receives FDA approval for retinal vein occlusion. HCP Live. October 27, 2023. Accessed July 5, 2024. https://www.hcplive.com/view/faricimab-vabysmo-receives-fda-approval-for-retinal-vein-occlusion.
3. Genentech. The Lancet Publishes Studies Showing Genentech’s Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months. Genentech: Press Releases | Monday, Jan 24, 2022. January 24, 2022. Accessed July 5, 2024. https://www.gene.com/media/press-releases/14941/2022-01-24/the-lancet-publishes-studies-showing-gen.
4. Khanani AM, Kotecha A, Chang A, et al. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology. Published online February 19, 2024. doi:10.1016/j.ophtha.2024.02.014
5. Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6
6. Wong TY, Haskova Z, Asik K, et al. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology. 2024;131(6):708-723. doi:10.1016/j.ophtha.2023.12.026
7. Iapoce C. Ramin Tadayoni, MD, Phd: 72-week data on Faricimab in retinal vein occlusion. HCP Live. February 1, 2024. Accessed July 5, 2024. https://www.hcplive.com/view/ramin-tadayoni-md-phd-72-week-data-faricimab-retinal-vein-occlusion.