Topline Phase 3 Results Report Faricimab Improved Vision in RVO Treatment

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Genentech indicates faricimab-svoa achieved its primary endpoint of non-inferiority to aflibercept in RVO treatment in the phase 3 BALATON and COMINO trials.

New positive topline results report that faricimab-svoa (Vabysmo) achieved its primary endpoint of noninferiority to aflibercept in people with retinal vein occlusion (RVO).

The findings, from Genentech, suggest that people with macular edema due to branch RVO (BRVO) and central RVO (CRVO) achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four weeks in the phase 3 BALATON and COMINO clinical trials.

Faricimab-svoa additionally showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness (CST). Both studies showed it to be well-tolerated and the safety profile was consistent with previous trials.

“These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss,” said Levi Garraway MD, PhD, chief medical officer and head of Global Product Development in the press release. “Today’s results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities.”

The company indicated detailed results will be presented at an upcoming medical meeting and additionally submitted to regulatory authorities across the globe.

The study agent is the first bispecific antibody approved for the eye, targeting and inhibiting two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

Ang-2 and VEGF-A may contribute to vision loss by destabilizing blood vessels, forming new leaky blood vessels and increasing inflammation. By blocking the pathways involving Ang-2 and VEGF-A, faricimab-svoa is designed to stabilize blood vessels. Ang-2 levels are elevated in RVO and increased Ang-2 expression is believed to drive disease progression.

Currently, faricimab is the only injectable eye medicine approved simultaneously for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) by the US Food and Drug Administration (FDA).

The agent has the option for treatments from one to four months apart in the first year following 4 initial monthly loading doses after evaluation of a patient’s anatomy and vision outcomes. Its long-term efficacy and safety in both wet AMD and DME was demonstrated by two-year data from four large, global studies with more than 3,000 participants.