Roche’s VEGFxAng2 bispecific antibody faricimab has matched Regeneron’s blockbuster Eylea in two phase 3 diabetic macular edema clinical trials. Faricimab was non-inferior to Eylea despite people on the experimental drug transitioning to a 16-week dosing window during the study.
Eylea is the dominant force in the diabetic macular edema market, in part due to its less burdensome dosing schedule in comparison to Roche and Novartis’ once-monthly rival Lucentis. Roche advanced faricimab into two phase 3 trials that pitted it against Regeneron and Bayer’s Eylea in a bid to step up its challenge to the incumbent diabetic macular edema drug.
Monday, Roche said both trials found faricimab was non-inferior to Eylea in terms of change in the best-corrected visual acuity (BCVA) from baseline after one year of treatment. Investigators assessed BCVA using a standard vision testing tool featuring rows of progressively smaller letters.
Patients on faricimab and Eylea both began the trial receiving injections every eight weeks. Subjects in the faricimab personalized dosing arms could change to longer gaps between injections during the study. After one year, more than half of people in the personalized dosing arms were going 16 weeks between injections.
Investigators have given Eylea as infrequently as every 16 weeks in a phase 4 trial. In that study, more than 40% of patients had moved to a 16-week schedule after being on Eylea for 96 weeks. With the caveat that cross-trial comparisons can be unreliable, the data suggest faricimab may have an edge over Eylea in terms of getting patients quickly onto a 16-week schedule.
It is unclear whether that apparent edge will be enough to turn faricimab into a major product. One issue for Roche is faricimab will likely need to compete with Eylea and biosimilar copies of Regeneron and Bayer’s blockbuster. Mylan, Samsung Bioepis and Amgen are among the companies with copies of Eylea in development. Filings for FDA approval could start next year, led by Mylan.
The arrival of biosimilar versions of Eylea means Roche may need to persuade payers that the dosing benefits of faricimab justify a premium price over off-patent rivals. Details of the phase 3 data may strengthen Roche’s effort to differentiate faricimab from its competitors, but the company is yet to share numbers from the two phase 3 trials.
Roche is working to generate more data on faricimab. A phase 3 assessment of the long-term safety and tolerability of faricimab is underway, as are pivotal trials designed to show the efficacy of the drug in neovascular or “wet” age-related macular degeneration.