Genentech (a member of the Roche Group [SIX: RO, ROG; OTCQX: RHHBY]) have announced positive top-line results from two identically designed global Phase III studies, “YOSEMITE” (NCT03622580) and “RHINE” (NCT03622593), evaluating an investigational bi-specific antibody, “faricimab”, for patients with diabetic macular edema (DME). The primary end-point was met in both studies, using the average change from baseline in BCVA at 1-year. The company will publish the detailed results and statistical reporting in due course. Genentech also announced that faricimab is the first investigational bispecific antibody designed for the eye targeting two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
According to the company, the antibody was designed to stabilise blood vessels, potentially resulting in better vision outcomes, for longer for people living with retinal conditions. Dr. Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development stated that, “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”. Both YOSEMITE and RHINE studies showed that the antibody were administered every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept (Eylea, Regeneron Pharmaceuticals) given every eight weeks. According to Genentech, the patients enrolled generally showed good tolerance, with “no new safety signals identified”. 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.
In the global phase III studies, efficacy and safety of faricimab were compared to aflibercept in 1,891 participants living with diabetic macular edema (940 in YOSEMITE and 951 in RHINE), faricimab 6.0 mg (dosing intervals of up to 16 weeks or fixed eight-week intervals), and aflibercept 2.0 mg (dosing at fixed eight-week intervals). The details for the specific data and presentation is scheduled at the Angiogenesis, Exudation and Degeneration (virtual) meeting in February, 2021 however, a key critical aspect will depend on how the dosing regimens can differentiate the two treatments in the ophthalmic market. In the backdrop to the study data, there is now a cue of biosimilar products in the pipelines from Mylan, Samsung Bioepis, Amgen and others.