While awaiting an FDA decision regarding a higher-dose version of Eylea (aflibercept), Regeneron has consistently emphasized the durability of their product compared to Roche’s competitive Vabysmo, which has made significant inroads in the macular degeneration market following its approval 19 months ago.
Regeneron now possesses more compelling evidence to support this assertion, thanks to a Phase III study. This study reveals that after administering 8 mg injections of aflibercept over a two-year span, 88% of patients managed to extend their dosage intervals to at least 12 weeks. The PULSAR trial also demonstrated that 71% of patients fulfilled the criteria for prolonged dosing intervals, with 47% achieving intervals of 20 weeks or more, and 28% meeting the criteria for 24-week intervals. The research further highlighted that throughout the two-year study, 78% of patients sustained dosing intervals of 12 weeks or more.
Roche is celebrating the strong adoption of its Eylea rival, Vabysmo, while also commending the customer shift from its competitor’s product. The outcomes from the PULSAR study, conducted in partnership with Bayer, are consistent with the findings from the PHOTON trial, overseen by Regeneron. These results were published in June, coinciding with the announcement that Regeneron’s application for the approval of 8 mg aflibercept had been declined by the FDA due to manufacturing concerns.
During its recent quarterly report, Regeneron disclosed that third-party manufacturer Catalent would be submitting crucial information in the middle of the present month, potentially paving the way for approval by the end of the third quarter.
The company also revealed in its presentation that sales of Eylea have hit a plateau. The second-quarter revenue of $1.5 billion mirrored the figure from the preceding quarter, indicating a 7% decrease compared to the same period in 2022.
Conversely, last month, Roche reported that Vabysmo had garnered sales of 957 million Swiss francs ($1.1 billion) during the first half of this year. With its capacity to extend injection intervals for numerous patients to once every four months, Vabysmo entered the market with considerable hype as a viable alternative to Eylea, which necessitates injections every two months.
As Regeneron accentuates the clinical outcomes from its 8 mg dose of aflibercept, suggesting its superior sustainability compared to Vabysmo, Roche has countered with findings from head-to-head trials illustrating that Vabysmo yields better retinol drying than Eylea.
Roche’s Vabysmo Demonstrates Advantages in Retina Drying Over Regeneron’s Eylea
At the American Society of Retina Specialists conference last month, Roche subsidiary Genentech presented an analysis of post-hoc data pooled from the YOSEMITE and RHINE trials. These findings indicated that Vabysmo resulted in less fibrosis than Eylea in patients with diabetic macular edema (DME).
Post-hoc data from these and other trials also highlighted that over half of the AMD and DME patients treated every 16 weeks met the criteria to extend their dosing intervals to every 20 weeks.
