The European Commission (EC) has approved Roche’s Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people.
“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 Prof Ramin Tadayoni, head of the ophthalmology department, Lariboisière, Saint-Louis and Rothschild Hospitals, Paris, France, and European Society of Retina Specialists (EURETINA) 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.”
Vabysmo is the only injectable eye medicine approved in Europe with phase III studies supporting treatment at intervals of up to four months for people living with nAMD and DME. With the potential to require fewer eye injections over time, while also improving and maintaining vision and anatomy, Vabysmo could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systems.
“The approval of Vabysmo in Europe is the result of years of pioneering research from Roche ophthalmologists and scientists, who are deeply committed to improving outcomes for people with retinal conditions,” said Levi Garraway, M.D., PhD., Roche’s chief medical officer and head of Global Product Development. “We are delighted to offer people in Europe this first-of-its-kind treatment option and are working to bring Vabysmo to people with nAMD and DME as soon as possible.”
The approval is based on results across four phase III studies in two indications, involving 3,220 patients: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years. The studies 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. Additionally, up to two years, people with nAMD and DME treated with Vabysmo received 33% (10 vs. 15) and 21% (11 vs. 14) fewer median number of injections compared to aflibercept, respectively.
Vabysmo, a bispecific antibody, is uniquely engineered to target and inhibit 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), to restore vascular stability. By independently blocking both pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels and thereby reduce inflammation, leakage and abnormal vessel growth (neovascularisation) more than inhibition of VEGF-A alone. This sustained blood vessel stabilisation may improve disease control, vision and anatomical outcomes for longer.
Vabysmo is now approved in the European Union and nine other countries around the world, including the US, Japan, and the UK, for people living with nAMD and DME, and submissions to other regulatory authorities are ongoing. Globally, more than 100,000 Vabysmo doses have been distributed for treatment of these conditions to date. Roche also continues to explore areas where Vabysmo has the potential to deliver additional benefits to patients, including retinal vein occlusion.