In January, when Roche’s Vabysmo won approval to treat wet-age macular degeneration, the nod was bolstered by late-stage studies that indicated the injected drug had more staying power than Bayer and Regeneron’s dominant treatment Eyela.
Six months later, Vabysmo’s edge is becoming clearer with results that demonstrate that the drug is just as effective and doesn't have to be dosed as often as Eylea, which is administered to patients at one- to two-month intervals.
In the Tenaya and Lucerne trials, after two years on Vabysmo, more than 60% of patients could be treated every four months—a significant improvement on the one-year data which showed 45% of them could be extended to four-month intervals. Nearly 80% of patients could go at least three months between injections, the latest data showed.
Over the two-year span, patients on Vabysmo needed a median of 10 injections, while patients on Eylea required a median of 15 shots.
“The second-year data looks better than the first-year data,” lead investigator Arshad Khanani, M.D., said in an interview. “This is exciting for patients and physicians.”
Investigators presented the results Thursday morning at the American Society of Retina Specialists annual scientific meeting.
In both studies, patients were given Vabysmo at intervals of two, three or four months or Eylea every two months. In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to the drug. In the study, there was no attempt to extend the dosing interval for Eylea.
Optical Coherence Tomography (OTC) tests also showed that stretching out the dosing schedule for Vabysmo didn't compromise disease control when compared with Eylea.
The believed key to the success of Vabysmo—which was in development for more than a decade—is that it inhibits both the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Eylea, on the other hand, targets just VEGF-A.
“There’s a ceiling effect in my opinion with VEGF-A inhibition,” Khanani said. “I do believe it’s the dual inhibition that’s playing the role here.”
Traveling to a doctor’s office and getting an injection directly into the eye is an onerous routine, so much so that many patients struggle with compliance. Going three times a year as opposed to six or more visits would give many more patients reason to continue treatment for the condition which is one of the top causes of blindness.
“Based on this data, I’m going to start extending patients one month at a time instead of two weeks at a time,” Khanani said. “If patients come and see me three or four times a year versus six times a year, that’s really good news.”
Eylea’s sales totaled $8.9 billion, making it the world’s ninth-highest selling pharmaceutical product in 2021. Regeneron is working on a high-dose version that would be administered every four months.
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