Roche targets wet AMD with new data and more efficient dosing

Pharma News: Roche’s ophthalmology drug faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with “wet” age-related macular degeneration (nAMD).

It has been more than 15 years since a medicine with a new mechanism of action has been approved to treat nAMD. Faricimab is the first bispecific antibody designed for the eye. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including nAMD.

With faricimab Roche is aiming to outperform rivals Novartis and Bayer in a highly competitive market.

Roche’s almost quarterly dosing regimen and the reduction to clinical practice visits would be welcomed due to cost reduction for patients and lower administrative burden for healthcare systems.

“These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We have now seen positive and consistent results in four phase III studies for faricimab across both neovascular age-related macular degeneration and diabetic macular oedema. We look forward to submitting these data to global regulatory authorities, with the aim of bringing this promising treatment option to patients as soon as possible.”

Both TENAYA and LUCERNE studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving Eylea (aflibercept) injections every eight weeks.

Nearly 45% of people in both studies were treated with faricimab every 16 weeks during the first year. This is the first time this level of durability has been achieved in a phase III study of an injectable eye medicine for nAMD.

The findings from TENAYA and LUCERNE build on positive topline results from the phase III YOSEMITE and RHINE studies, announced in December 2020, which support the potential of faricimab as a treatment option for diabetic macular oedema, a leading cause of vision loss among working-age adults.