Roche has announced four-year results from the RHONE-X extension study, which evaluated the long-term safety and efficacy of Vabysmo (faricimab) in treating diabetic macular oedema (DME).
The multicentre study included 1,474 DME patients who completed either the Phase III YOSEMITE or RHINE studies.
The trial subjects were previously treated with either Vabysmo or aflibercept in the initial studies.
They were all administered Vabysmo on a personalised treatment interval during the RHONE-X study.
Long-term safety and tolerability of the treatment, including ocular adverse events (AEs), non-ocular AEs and anti-drug antibodies’ presence were the study’s primary objectives.
An exploratory goal was to evaluate the ongoing efficacy of the treatment.
According to the latest data, the study met all primary endpoints, confirming that Vabysmo was well-tolerated by DME patients over a treatment period of up to four years.
Exploratory results further revealed that it continued to maintain vision, reduce retinal fluid, and extend the duration between treatments for individuals with DME.
Moreover, the exploratory analysis indicated that participants maintained vision improvements and retinal fluid reduction, as seen in the YOSEMITE and RHINE studies.
Over 90% of those treated achieved an absence of DME, with central subfield thickness measurements falling below 325 microns.
Vabysmo has received approval in around 100 countries for the treatment of DME and wet age-related macular degeneration (nAMD).
It is also intended to treat macular oedema following retinal vein occlusion in various nations, including the US and Japan.
Since its initial approval in the US in 2022, over four million doses of Vabysmo are claimed to have been distributed globally.
Roche Global Product Development head and chief medical officer Levi Garraway said: “These four-year data build on our pivotal studies and reinforce Vabysmo’s potential to become standard of care treatment for diabetic macular oedema, which affects 29 million people worldwide.
“We are especially pleased to see that nine out of ten patients showed no sign of DME after four years of treatment with Vabysmo, which is an incredible long-term outcome for people living with this condition.”
The latest development comes after the company reported positive data from the Phase I trial of CT-996 to treat type 2 diabetes (T2D) and obesity.
