Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies.

While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab produces a similar effect but with a 16-week dosing regimen.

Roche’s approach is similar to that taken by Novartis with its ophthalmology drug Beovu (brolucizumab), which can be taken three months apart by some patients in wet age-related macular degeneration, another indication where Eylea is well established.

Roche’s two non-inferiority trials met their main goals, showing that that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks gave similar visual acuity gains compared with Eylea given every eight weeks.

Faricimab was generally well-tolerated, with no new safety signals identified, Roche said.

The studies each have 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 a secondary endpoint, across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one.

This is the first time any investigational medicine has achieved this level of durability in a phase 3 study of people with DME, Roche noted.

Faricimab also has different mechanism of action compared with Eylea and is the first bispecific antibody designed especially for the eye.

It targets two pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME.

Roche is also testing the long-term safety and tolerability of faricimab in DME in the phase 3 Rhone-X study.

Detailed results of YOSEMITE and RHINE will be presented at the Angiogenesis, Exudation and Degeneration 2021 medical conference in Miami next month, and filed with regulators around the world.