Roche’s faricimab hits the mark in diabetic macular edema study

Swiss pharma company Roche has announced that its investigational bispecific antibody faricimab met the primary endpoint across two phase III studies in diabetic macular edema (DME), a leading cause of vision loss.

Faricimab targets two pathways involved in vision loss – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

These pathways drive vision loss by destabilising blood vessels, which results in new leaky blood vessels to form and increasing inflammation.

The two identically designed phase III studies – YOSEMITE and RHINE – evaluated faricimab in people living with DME compared to Regeneron’s Eylea (aflibercept).

Both studies met their primary endpoints, with faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrating non-inferior visual acuity gains compared to Eylea given every eight weeks.

In addition, the secondary endpoint across both studies showed that over half of participants treated in the farcimab arms achieved an extended time between treatments of 16 weeks at year one.

According to Regeneron, this marks the first time an investigational medicine has achieved this level of durability in a phase III DME study.

“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” said Levi Garraway, chief medical officer and head of global product development.

“We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible,” he added.

Roche will be present the detailed results from the YOSEMITE and RHINE studies at the upcoming  Angiogenesis, Exudation, and Degeneration 2021 medical symposium.

The investigational medicine will also be submitted for approval for the treatment of DME with global health authorities, the company added.