Genentech’s injectable eye medicine extends time between treatments for two conditions

pharmafile | February 15, 2021 | News story | Sales and Marketing Genentech 

Genentech has announced detailed, positive results from four Phase III studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular oedema (DME) and neovascular or “wet” age-related macular degeneration (nAMD).

The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared with aflibercept, given every two months.

Approximately half of people eligible for extended dosing with the drug were able to be treated every four months in the first year in the YOSEMITE and RHINE studies in DME, and the TENAYA and LUCERNE studies in nAMD.

Faricimab is the first injectable eye medicine to achieve this length of time between treatments in Phase III studies for DME and nAMD. Additionally, around three-quarters of people eligible for extended dosing with the drug were able to be treated every three months or longer in the first year. The treatment was generally well-tolerated in all four studies, with no new or unexpected safety signals identified.

While anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME and nAMD, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.

Faricimab is the first investigational bispecific antibody designed for the eye, and unlike current treatments for DME and nAMD that inhibit the VEGF pathway, it targets two distinct pathways that drive a number of retinal conditions. Through this novel mechanism of action, the medicine is designed to stabilise blood vessels, and thereby reduce inflammation and leakage, more than inhibiting either pathway alone.

Dr Jeffrey Heier, Director of Retinal Research at Ophthalmic Consultants of Boston in the US, said: “These faricimab data offer the promise of a new treatment for two common causes of blindness, diabetic macular oedema 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.”

Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, 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 oedema.

“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.”

Darcy Jimenez

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