Regeneron's high-dose Eylea shows staying power as company awaits FDA decision

As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its durability compared to that of Roche’s upstart Vabysmos—which has taken the macular degeneration (AMD) market by storm since receiving approval 19 months ago.

Regeneron now has more ammunition to back up that claim as a phase 3 study shows that after receiving 8 mg injections of aflibercept over a two-year period, 88% of patients were able to extend their dosage to at least 12-week intervals. The PULSAR trial also demonstrated that 71% of patients met the extension criteria for longer dosing intervals, with 47% reaching intervals of 20 or more weeks and 28% reaching criteria for 24-week intervals. The study also showed that 78% of patients were able to maintain 12-week or more dosing intervals throughout the two-year study period.

"In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year one through year two," trial investigator Charles Wykoff, M.D., Ph.D., director of research at Retina Consultants of Texas, said in a release.

Results of the PULSAR study, which was run by commercial partner Bayer, matched up with those from the PHOTON trial, which was conducted by Regeneron. Data from that study were released in June, the same day that the company reported that the FDA had rejected an application for approval of 8 mg aflibercept because of manufacturing issues.

During its quarterly report last week, Regeneron said that third-party manufacturer Catalent would submit information in the middle of this month that could clear the way for an approval by the end of the third quarter.

The company also revealed during its presentation that sales of Eylea have stagnated. The $1.5 billion generated in the second quarter matched the figure from the previous quarter and was a 7% decline from the same period in 2022.

Meanwhile last month, Roche reported that sales of Vabysmo had reached 957 million Swiss francs ($1.1 billion) in the first half of this year. With its ability to extend injection intervals for many patients to once every four months, Vabysmo hit the market with much fanfare as an alternative to Eylea, which requires a shot every two months.

As Regeneron has touted the clinical results of its 8 mg dose of aflibercept—which suggest that it has superior staying power to Vabysmo—Roche has countered with trial results which suggest that Vabysmo provides better drying of the retina than Eylea.

Last month, at the American Society of Retina Specialists conference, Roche subsidiary Genentech presented post-hoc analysis of pooled data from the YOSEMITE and RHINE trials which showed Vabysmo led to less fibrosis than Eylea in patients with diabetic macular edema (DME).

Post-hoc data from these and other trials also showed that more than half of AMD and DME patients who were treated every 16 weeks met criteria to extend their dosing intervals to every 20 weeks.