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Genentech announced the FDA had approved faricimab-svoa (Vabysmo) for retinal vein occlusion on October 26, 2023, which marks the third ophthalmic indication for the bispecific antibody.
The US Food and Drug Administration has approved faricimab-svoa (Vabysmo) for the management of retinal vein occlusion (RVO), according to a release from Genentech.
The approval, which was announced on October 26, 2023, is based on a pair of phase 3 trials assessing the noninferiority of the agent against aflibercept in patients with RVO and represents the third indication for faricimab, which boasts previous approvals for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
“Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech.1 “The efficacy and safety profile of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated.”
With approval in January 2022 for AMD and DME based on the TENAYA and LUCERNE trial, faricimab became the first and only bispecific antibody approved for an ophthalmic condition. Following these approvals, Genentech filed a supplemental Biologics License Application for faricimab in the treatment of retinal vein occlusion during May of 2023, with this application backed by data from the phase 3 BALATON and COMINO trials.2
In the BALATON and COMINO trials, patients were randomized 1:1 to receive 6 monthly injections of either faricimab 6.0 mg or aflibercept 2.0 mg for the first 20 weeks. From weeks 24 - 72, all patients received faricimab 6.0 mg up to every 4 months, according to a personalized treatment interval dosing regimen and using a treat-and-extend approach.2
The BALATON study included 553 patients with branch RVO, and the COMINO study included 729 patients with central retinal or hemiretinal vein occlusion. Each study’s primary endpoint is the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks, with secondary endpoints including the change in central subfield thickness (CST) from baseline over time up to 24 weeks.2
For both studies, the average vision gains from baseline were comparable with faricimab and aflibercept treatment. In BALATON, vision gains were +16.9 eye chart letters in the faricimab arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the faricimab arm and +17.3 letters in the aflibercept arm at 24 weeks.2
Analysis of secondary endpoints suggested use of faricimab was associated with rapid and robust drying of retinal fluid, comparable to aflibercept. In BALATON, the CST reductions from baseline at 24 weeks were 311.4 µm in the faricimab arm and 304.4 µm in the aflibercept arm. In COMINO, the CST reductions from baseline at 24 weeks were 461.6 µm in the faricimab arm and 448.8 µm in the aflibercept arm.2
At Angiogenesis, Exudation and Degeneration 2023, 72-week follow-up data from these trials was presented. This data suggested use of faricimab was associated with sustained anatomical improvements, with robust and sustained improvement of retinal fluid from baseline up to 72 weeks.3
“These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch RVO,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, in an October 9, 2023 release from Genentech.3
According to Genentech, the safety profile observed in the BALATON and COMINO trials were consistent with those established in previous trials of faricimab. The most common adverse events in the trials was conjunctival hemorrhage, which occurred in 3% of patients.1
In their release, Genentech pointed out new information had been added to the Warnings & Precautions section of the US label based on rare post-marketing cases of retinal vasculitis and/or retinal vascular occlusion, which the release notes typically occur in the presence of intraocular inflammation. The release also noted the reported rate of retinal vasculitis with vascular occlusion is in line with real-world reported frequencies of other intravitreal treatments for people with wet AMD, DME, and RVO.1