New data from a phase 3 trial measuring Roche’s Vabysmo versus Regeneron and Bayer’s Eylea in retinal vein occlusion (RVO) shows that more patients on Vabysmo had an absence of blood vessel leakage in the retina.
While this pre-specified exploratory endpoint helps build a case for Vabysmo to be approved for RVO, it also could have far-reaching implications in Roche’s budding battle with Regeneron in the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
The results come from the phase 3 BALATON and COMINO studies. Roche touted positive topline results from the trials in October, but Vabysmo's performance on this secondary endpoint—observed across both trials—could offer clues about how the rival drugs will stack up against each other in their ongoing market clash.
On Saturday, Roche will present its most recent findings on Vabysmo virtually at the Angiogenesis, Exudation and Degeneration 2023 meeting, including additional evidence that Vabysmo's advantage in retinal drying over Eylea extends to DME and AMD.
A year ago, Vabysmo won FDA approval to treat both AMD and DME with a longer-acting formula than Eylea, the dominant drug in the arena, with U.S. sales of more than $6.25 billion in 2022.
After an introductory phase of treatment, Vabysmo has allowed many patients to get by with three doses per year versus six for Eylea, a key advantage considering administration is by way of a shot to the eyeball.
Demonstrating an edge with less retinal leakage would be important. A drier retina with less swelling and fluid generally means clearer vision.
In October, Roche released data from the two studies which enrolled 1,282 patients and pitted Vabysmo against Eylea in those with macular edema caused by branch and central retinal vein occlusion (BRVO and CRVO respectively). After 20 weeks of introductory treatment (one dose every four weeks), Vabysmo met its primary endpoint, showing non-inferiority compared with Eylea in visual acuity at week 24.
As a secondary endpoint, the trials also compared the drying of retinal fluid as measured by central subfield thickness. In both studies, reductions were comparable.
But both trials also showed that more patients on Vabysmo had an absence of blood vessel leakage in the retina compared to Eylea. In the BRVO group, 34% of Vabysmo patients had no leakage versus 21% on Eylea. In the CRVO group, the figures were 44% (Vabysmo) versus 30% (Eylea).
When fluid becomes trapped within and under the retina in RVO, it can lead to rapid vision loss if left untreated, explained Ramin Tadayoni, M.D., Ph.D., the president-elect of the European Society of Retina Specialists (EURETINA), in an interview.
"The faricimab (Vabysmo) studies versus Eylea are non-inferiority studies and faricimab has yet to show superiority over Eylea in the treatment of diabetic macular edema, wet age macular degeneration and retinal vein occlusion," Regeneron said in a statement.
For its part, Regeneron has answered Vabysmo's longer-lasting formula with one of its own. Last year, the company presented data that suggest its new, souped-up version of Eylea has superior staying power than that of Vabysmo, though that has not been proven in a head-to-head trial.
In Regeneron's phase 3 study, 77% of patients with wet age-related macular degeneration (AMD) and 89% of those with diabetic macular edema (DME) were able to sustain a once-every-four-months regimen. In Vabysmo's trail, the corresponding figures were 45-46% in AMD and 51-53% in DME.
EDITOR'S NOTE: A statement from Regeneron was added to this story after it was originally published.