FDA Approves Faricimab for Macular Edema Following Retinal Vein Occlusion

The FDA has approved faricimab-svoa (Vabysmo; Genentech) to treat macular edema following retinal vein occlusion (RVO). This marks the third approved indication for faricimab, which has also been approved to treat wet or neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). These 3 conditions are among the top causes of vision loss, affecting approximately 3 million patients in the United States.

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“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, Genentech’s chief medical officer and head of Global Product Development. “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.”

Faricimab is the first bispecific antibody granted FDA approval for eye-related conditions. The medication targets and inhibits 2 signaling pathways associated with several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), according to Genentech.

The latest approval for faricimab was based on positive data from the global, phase 3 BALATON (NCT04740905) and COMINO (NCT04740931) studies. Both of the randomized, multicenter, double-masked, global, phase 3 trials analyzed the efficacy and safety of faricimab compared to aflibercept.

Investigators in the BALATON study enrolled 553 patients with branch RVO, whereas COMINO included 729 patients with central retinal or hemiretinal vein occlusion. Both studies had a primary endpoint of change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints in both trials from weeks 0-24 included changes in central subfield thickness and drying of retinal fluid. Secondary endpoints from weeks 24-72 were treatment durability at 68 weeks and continuation of the endpoints from weeks 0-24.

For the first 20 weeks of both trials, patients were randomly assigned 1:1 to receive monthly injections of either faricimab 6.0 mg or aflibercept 2.0 mg for 6 months. From weeks 24 to 72, all patients were administered faricimab 6.0 mg up to every 4 months using a treat-and-extend dosing regimen.

These trials showed that monthly therapy with faricimab produced early and sustained vision improvements in patients with branch and central RVO, which achieved the primary endpoint of non-inferior visual acuity gains at 24 weeks compared with treatment with aflibercept. Faricimab also led to rapid and robust drying of retinal fluid.

In both phase 3 trials, faricimab was found to be generally well tolerated with a safety profile across the study cohorts that was consistent with prior trials. The most common adverse event was conjunctival hemorrhage (3%).

The Warnings and Precautions section of the US label of faricimab was updated for rare post-marketing cases of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation. Rates of retinal vasculitis with vascular occlusion were reported as 0.06 per 10,000 injections, which was in line with the real-world reported frequencies of other common intravitreal treatments for patients with wet AMD, DME, and RVO.

Reference

FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO). Genentech. News release. October 26, 2023. https://www.gene.com/media/press-releases/15009/2023-10-26/fda-approves-genentechs-vabysmo-for-the-