The European Commission (EC) has approved Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ Age-Related Macular degeneration (nAMD) and visual impairment due to Diabetic Macular Edema (DME), Roche notified via a statement.
According to the statement, 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 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 per cent 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 per cent (10 vs. 15) and 21 per cent (11 vs. 14) fewer median number of injections compared to Aflibercept, respectively, added the statement.
It also said that Vabysmo is 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.