Clinical Trials
Genentech announces results from two phase 3 trials of retinal vein occlusion treatment
Genentech has announced positive topline long-term results from its global phase 3 BALATON and COMINO trials, which assessed extended treatment intervals with Vabysmo (faricimab-svoa) in macular oedema due to branch and central retinal vein occlusion (BRVO and CRVO).
The trials demonstrated that patients treated with the drug extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials. The drug continued to show robust and sustained drying of retinal fluid from baseline to week 72, measured by reduction in central subfield thickness.
In both trials, Vabysmo was well tolerated with a safety profile consistent with its previous trials.
Data from weeks 24 to 72 of the trials is expected to be presented at an upcoming medical meeting; data up to week 24 has already been presented and has been submitted to global health authorities including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), with a decision from the FDA expected in late 2023.
Levi Garraway MD PhD, Genentech’s chief medical officer and head of Global Product Development, commented: “These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch retinal vein occlusion. These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition.”