Roche has announced the approval of Vabysmo (faricimab) by the European Commission (EC) for the treatment of neovascular age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME), two leading causes of vision loss.
The company noted that Vabysmo, a bispecific antibody, is the only injectable eye medicine approved in Europe with phase 3 studies supporting treatment at intervals of up to four months for people living with nAMD and DME.
“Many people with nAMD and DME struggle to keep up with the monthly eye injections and physician visits, often associated with current standards of care, and unfortunately their vision may suffer as a result of undertreatment,” said Professor Ramin Tadayoni, head of the ophthalmology department, Lariboisière, Saint-Louis and Rothschild Hospitals, and European Society of Retina Specialists president-elect.
“For people in Europe living with these conditions, today’s approval offers the first new mechanism of action in over a decade; one which could improve and protect their vision with fewer injections over time,” Tadayoni added.
The EC’s approval is based on results across four phase 3 studies in two indications that showed that people treated with Vabysmo, given at intervals of up to four months, achieved ‘similar vision gains and anatomical improvements’ compared to aflibercept given every two months.
The totality of data across all four studies at two years showed that more than 60% of people treated with Vabysmo were able to extend treatment to every four months, while improving and maintaining vision, Roche outlined.
nAMD, which affects 20 million people worldwide, develops when new and abnormal blood vessels grow uncontrollably under the macula, resulting in swelling, bleeding and/or fibrosis.
Meanwhile, DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving – and affects around 21 million people worldwide.
Both conditions are associated with blindness and decreased quality of life when left untreated.
Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), both thought to contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation.