Positive phase III data for Roche’s vision loss therapy

Positive phase III data for Roche’s vision loss therapy

New phase III data show Roche’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients.

The four phase III studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and RHINE studies in diabetic macular edema (DME) and the TENAYA and LUCERNE studies in neovascular age-related macular degeneration (nAMD).

Faricimab is the first injectable eye medicine to achieve this length of time between treatments in phase III studies for DME and nAMD. Furthermore, approximately three-quarters of people eligible for extended dosing with faricimab were able to be treated every three months or longer in the first year. Faricimab was generally well-tolerated in all four studies, with no new or unexpected safety signals identified. If approved, faricimab would be the first in a new class of medicine in 15 years for people with nAMD and in close to a decade in DME.

Jeffrey Heier, M.D., Director of Retinal Research at Ophthalmic Consultants of Boston in Boston, MA said: “These faricimab data offer the promise of a new treatment for two common causes of blindness, diabetic macular edema and neovascular age-related macular degeneration. Faricimab’s potential to extend time between treatments may benefit those patients who struggle to keep up with the regular physician visits and eye injections needed to preserve their vision.”

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said: “These positive results show the potential for faricimab as the first new type of medicine in 15 years for people with neovascular age-related macular degeneration and in close to a decade in diabetic macular edema. This is an exciting time for our ophthalmology clinical development programme, with multiple phase III successes for two medicines from our late-stage pipeline. We hope to bring these potential treatments to people living with vision-threatening retinal conditions as soon as possible.”