Roche Vabysmo matches Eylea in 2 phase 3 trials for eye disorder
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Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) drug Vabysmo met the main goal in two phase 3 trials showing visual acuity gains as good as Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) and Regeneron Pharmaceuticals' (REGN) Eylea (aflibercept) in people with retinal vein occlusion (RVO).
The studies BALATON and COMINO, evaluated Vabysmo (faricimab) versus Eylea (aflibercept 2 mg) in people with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) for 20 weeks, with the main goal measured at week 24.
Roche said Vabysmo showed non-inferior visual acuity gains compared to aflibercept. The average vision gains from baseline were comparable between the two treatments in both studies.
In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo group and +17.5 letters in the Eylea arm at 24 weeks.
In COMINO, vision gains were +16.9 letters in the Vabysmo group and +17.3 letters in the Eylea group at 24 weeks. Additionally, the percentage of patients gaining 15 or more letters was comparable across treatment arms in both studies, according to the company.
Fluid in the retina in the back of the eye, which may be due to blood vessel leakage, can cause swelling and blurry vision â a secondary goal showed that Vabysmo achieved rapid drying of retinal fluid from baseline, as measured by reduction in central subfield thickness (CST).
In BALATON, CST reductions were -311.4 Î¼m in the Vabysmo group and -304.4 Î¼m in the aflibercept arm, while in COMINO, CST reductions were -461.6 Î¼m in the Vabysmo group and -448.8 Î¼m in the aflibercept group.
Roche noted that more patients showed an absence of blood vessel leakage in the retina compared to aflibercept in a pre-specified exploratory goal.
In BALATON, 34% of patients treated with Vabysmo had an absence of leakage compared to 21% on aflibercept. In COMINO, the rates were 44% for patients on Vabysmo, versus 30% for patients on aflibercept.
Roche said it will submit the data from the studies to regulators in the U.S. and EU for approval of Vabysmo to treat macular edema due to RVO.
If approved, RVO would be the third indication for Vabysmo in addition to neovascular or wet age-related macular degeneration and diabetic macular edema, according to the company.