Swiss drug giant Roche is poised to pursue regulatory clearance for its new faricimab antibody for diabetic macular edema (DME) after it produced a similar effect to Eylea in twin clinical trials, but with half the dosing regimen in several patients.
The company’s the Phase 3 Yosemite and Rhine studies met primary endpoints and showed faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept (Eylea) given every eight weeks.
Lessening the treatment burden on macular disease patients has become a key focus of pharmaceutical companies, with Novartis also focusing on extended treatment regimens with its drug Beovu for neovascular age-related macular degeneration (nAMD). Novartis also recently announced positive findings from its the Phase 3 trial (Kestrel) assessing the efficacy and safety of Beovu in DME.
According to Roche, more than half of participants in the faricimab personalised dosing arms had extended time between treatments of 16 weeks at year one – the first time this level of durability has been achieved in a Phase 3 DME study.
The company claims faricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
The studies each had three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase.
“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,” Dr Levi Garraway, Roche’s chief medical officer and head of global product development, said.
“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.”
Faricimab was generally well-tolerated, with no new safety signals identified, Roche said.
The drug is also being investigated in another Phase 3 study (Rhone-X) study looking into the long-term safety and tolerability of the drug for DME. Other Phase 3 (Tenaya and Lucerne) studies are assessing its potential as a nAMD therapy.
Detailed results from the Yosemite and Rhine studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, and submitted for approval for the treatment of DME around the world.