Roche (OTCQX:RHHBY) (OTCQX:RHHBF) on Thursday said its medicine Vabysmo was as good as Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) and Regeneron Pharmaceuticals’ (REGN) Eylea to treat a vision disorder in two phase 3 studies.
The Swiss pharma giant was evaluating Vabysmo (faricimab) in two phase 3 trials, BALATON and COMINO, against Eylea (aflibercept) to treat macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). BALATON is being conducted in 553 people with branch retinal vein occlusion, while COMINO is being carried out in 729 people with central retinal or hemiretinal vein occlusion.
Retinal vein occlusion (RVO) occurs when there is blockage in the vein in the retina, which can lead to vision loss.
Roche said both trials met their main goals, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those on aflibercept injections every four weeks.
Vabysmo also showed rapid drying of retinal fluid from the time treatment started through week 24, as measured by reduction in central subfield thickness, a secondary goal of the study.
The company added that Vabysmo was generally well tolerated and its safety profile was consistent with previous trials.
Roche said detailed results will submitted to regulatory authorities globally and also presented at an upcoming medical meeting.
Vabysmo is already approved in the U.S. EU and certain other countries to treat neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME), the company noted.