Roche eyes FDA filing after bispecific matches Eylea again

Roche’s bispecific faricimab has matched Regeneron’s Eylea in another pair of phase 3 clinical trials. The top-line results suggest the VEGFxAng2 bispecific antibody faricimab performs as well as Eylea in people with “wet” age-related macular degeneration (AMD) even when it is dosed half as often.

Investigators enrolled 1,329 people with wet, also known as neovascular, AMD across two identical phase 3 clinical trials. Participants on 6 mg of faricimab received the drug every eight, 12 or 16 weeks, depending on their disease activity at weeks 20 and 24. The remaining subjects received 2 mg of Eylea every eight weeks.

At 48 weeks, faricimab was non-inferior to Eylea on a test of visual acuity, causing the clinical trials to hit their primary endpoints. Roche is yet to share data on the primary endpoint or any analyses of the secondary objectives.

The only number released by Roche was the 45% of participants who moved to a 16-week faricimab dosing schedule during the first year of treatment. In an earlier pair of diabetic macular edema phase 3 trials, Roche saw “more than half” of participants adopt a 16-week schedule. The diabetic macular edema clinical trials also met their primary endpoints. 

While all four clinical trials met their primary endpoints, it is unclear whether non-inferiority will be enough to establish faricimab as a major product. Undergoing fewer intravitreal injections is likely to appeal to patients, but Eylea is an incumbent available on a less onerous dosing schedule than that used in the Roche clinical trials.

The current Eylea label permits dosing in AMD every 12 weeks, with the caveat that the schedule is less effective than the eight-week regimen, and researchers have given the antibody as infrequently as every 16 weeks in a post-approval clinical trial.

Roche will also face competition from players other than Regeneron and its Eylea partner Bayer. Samsung Bioepis and Biogen are gearing up to introduce a biosimilar copy of Lucentis in the U.S., and Eylea is set to come off patent in the next few years, forcing Roche to compete with rivals that are likely to undercut it on price. 

Details of whether Roche has the data to justify a price premium are imminent. Roche plans to share data from all four clinical trials at an event next month. The Swiss pharma company is also preparing to seek approval for faricimab in the U.S. and the EU.