Roche’s Vabysmo gains FDA approval for treating retinal vein occlusion

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Pharma giant Roche has secured the U.S. FDA’s approval for Vabysmo (faricimab) in treating macular edema after retinal vein occlusion (RVO). This becomes the third indication for Vabysmo, joining the ranks alongside neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Collectively, these three retinal ailments affect an estimated 70 million individuals globally, posing as primary vision loss causes.

The Unique Characteristics of Vabysmo

Levi Garraway, Roche’s Chief Medical Officer, emphasized the new treatment’s potency. “Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying,” he said. Highlighting its well-established efficacy and safety profile, Garraway added that the treatment’s value is further underlined by an expanding range of real-world evidence. Remarkably, Vabysmo is the pioneering bispecific antibody given a green signal for ocular use.

FDA approves Roche's Vabysmo for retinal vein occlusion: A first bispecific antibody for the eye

FDA approves Roche’s Vabysmo for retinal vein occlusion: A first bispecific antibody for the eye. Photo courtesy of F. Hoffmann-La Roche Ltd.

Clinical Studies Supporting Approval

The green light from the FDA for retinal vein occlusion treatment is grounded on encouraging outcomes from global phase III BALATON and COMINO studies. In these studies, monthly Vabysmo treatments led to early and consistent vision betterment in RVO patients, fulfilling the primary endpoint of matching visual acuity gains at 24 weeks to aflibercept. Further backing came from data indicating Vabysmo’s efficiency in rapidly and robustly drying retinal fluid. The safety profile observed was consistent with prior trials, with conjunctival haemorrhage (3%) being the most frequent adverse reaction.

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Safety Concerns and Global Acceptance of Vabysmo

Post-marketing instances of retinal vasculitis and/or retinal vascular occlusion, usually alongside intraocular inflammation, have been added to the U.S. label’s Warnings and Precautions segment. The reported retinal vasculitis rate with vascular occlusion aligns with real-world reported frequencies of other intravitreal treatments extensively employed for nAMD, DME, and RVO sufferers. Notably, Vabysmo’s global acceptance is evident, with approvals in 80+ countries for nAMD and DME treatments, and nearly 2 million doses distributed worldwide.

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