Its monoclonal antibody, Vabysmo (faricimab) was evaluated in clinical studies, BALATON and COMINO, assessing its effectiveness in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
In both trials, patients were randomised to receive six monthly injections of either Vabysmo (6.0 mg) or another eye drug, Bayer and Regeneron’s aflibercept (2.0 mg) for 20 weeks, with the primary endpoint measured at week 24.
The trial data showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept, branded as EYLEA, said the company.
Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness, reported Roche.
In both studies, the drug’s safety profile was consistent with previous trials, it added. The most common adverse reaction was conjunctival hemorrhage (3%). The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.
“Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated,” said Dr Ramin Tadayoni, professor of ophthalmology Université de Paris, who presented the data at Angiogenesis 2023 on February 11. “These promising results show that Vabysmo effectively reduces fluid in the retina and improves vision in patients with retinal vein occlusion (RVO).”
Regulatory filings
Roche is now set to submit those trial results to global regulatory agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), to support the regulatory filing of Vabysmo for 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 (nAMD) and diabetic macular edema (DME).
Vabysmo is approved in more than 50 countries around the world, including the US, Japan, the UK, and the EU for people living with nAMD and DME.