Roche eyes an uncertain market for faricimab

Usually a double pivotal trial hit would be cause for celebration, but it might not be enough for Roche.

Trial Results

You come at the king, you best not miss. And, to be fair, Roche’s faricimab did not miss exactly in its two head-to-head trials versus the leading diabetic macular oedema therapy, Regeneron’s Eylea. But neither did it land a knockout blow. 

Top-line data from the pivotal Yosemite and Rhine studies showed faricimab to be as good as Eylea at improving patients’ eyesight, and therefore the trials must be regarded as successes. But faricimab was supposed to differentiate itself via its more convenient dosing, and it is currently unclear how a less regular dosing schedule performed versus Eylea.

Another consideration is the changing competitive landscape, which might soon see Roche’s hopes for faricimab kyboshed by generic versions of its own Lucentis.

Dosing details

Full details of the identical Yosemite and Rhine studies will be presented at the Angiogenesis, Exudation and Degeneration meeting in February. For now all Roche has said is that its anti-VEGF/Ang2 bispecific was non-inferior to Eylea on change from baseline in best corrected visual acuity, the trials’ primary endpoint. But the dosing regimens are crucial here.

The trials each enrolled 950 patients and each had three arms. In the control, Eylea was injected into patients’ eyes once every two months. In another, faricimab was given on the same two-month schedule. But in the third arm, patients started with four once-a-month injections of Roche’s antibody, and then had their doses spread further apart if their doctors felt their vision was sufficiently good to do so. The gaps between doses were increased at one-month increments out to every four months. 

Roche said that after the first year of the trials more than half of participants in the adjusted-dose faricimab arms were on the four-month schedule – the first time this level of durability has been achieved in a phase III diabetic macular oedema study. 

Further apart

Non-inferiority to Eylea was achieved separately in both the adjusted-dose and every eight week arms. But there is a wrinkle: two years ago, Eylea was approved for administration once every three months after the first year of therapy – though it should be noted that the label states this schedule is “not as effective as the recommended every eight week dosing regimen”. 

Few people enjoy ocular injections. But it is not yet clear whether faricimab boasts a dosing advantage to justify a switch from Eylea. If the trials had shown superiority for faricimab this would be a different matter. 

There is one last complication. Lucentis, Roche’s longstanding diabetic macular oedema product, came off patent this summer and biosimilars could appear next year. Eylea itself sheds its US patent protection in 2023 and its European patent expires two years later. 

There is a very short period in which faricimab can make its mark, and it is not clear whether the Yosemite and Rhine data will allow much of a mark to be made.  

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