But the presenter downplayed the rivalry between the two new treatments for geographic atrophy. “I think we are lucky to have multiple therapies,” saidPaul Hahn, M.D., Ph.D. of NJRetina.
The FDA approved treatments for geographic atrophy for the first time last year,first Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) in February and then Astella Pharma’s Izervay (avacincaptad pegol) in August.
The approvals have presented retinal specialists in the U.S. (and their patients) with a choice to make.
Paul Hahn, M.D., Ph.D.
A presentation yesterday at the American Society of Retina Specialists ASRS) meeting in Stockholm, Sweden, comparing the two treatments would argue for picking Syfovre, although its reputation has been tarnished some by reports linking Syfovre to rare instances of retinal vasculitis. There is session on Syfovre’s safety scheduled for this afternoon.
Syfovre and Izervay have not been compared in a head-to-head clinical trial. Instead, Paul Hahn, M.D., Ph.D., used a statistical method called anchored matching-adjusted indirect comparison to compare the results from the two pivotal, phase 3trials of Syfovre, called OAKS and DERBY, to the results of the phase 3 trial of Izervay, called GATHER2.
GATHER2 was limited topatients with nonsubfoveal lesions (a subset of geographic atrophy). One of the adjustments Hahn made in his analysis was to narrow the patients in the OAKS and DERBY trials to those with that type of geographic atrophy.
Hahn, a retina specialist at NJRetina in northern and central New Jersey and a consultant to Apellis, shared results comparing monthly injections of Syfovre to monthly injections Izervay. He also compared patients who were treated Syfovre injections every other month to those who were treated with Izervay.
In the comparison of monthly injections, Syfovre produced a statistically significant 30% greater reduction in the growth of the geographic atrophy lesion than Izervay did after a year of treatment and Syfovre advantage persisted during a second year of treatment, according to results shared by Hahn.
In the comparison of every other month injections of Syfovre to monthly injections of Izervay, a trend favored Syfovre after a year of treatment but the difference did not reach the standards used to assess statistical significance, Hahn told the ASRS audience. But after two years of treatment, a 30% difference in geographic atrophy reduction favoring Syfovre over Izervay did reach statistical significance
Notwithstanding the nod his results give to Syfovre, Hahn downplayed any Syfovre-Izervay rivalry during the question-and-answer part of the morning session on dry age-related macular degeneration (AMD). Geographic atrophy is advanced form of dry AMD.
“I think we are lucky to have multiple therapies,” Hahn said. “The reasons to choose one drug versus another are multifactorial, whether is insurance-payer based or your own personal experiences or preferences, your practice accessibility, or formulary reasons and so forth.”
Hahn went to say, though, that while he tries to discuss the options with his patients, it is hard for him not to recommend Syfovre because of the one-year results he presented at last year’s ASRS meeting and the two-year results he presented this year.
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Results from retrospective real-world studies presented at American Society of Retina Specialists annual meetiing put the risk of retinal vasculitis from Syfovre at 1 in 1,330 patients. But other results presented at the meeting supplied evidence that Syfovre fends off vision loss caused by geographic atrophy, an advanced form of dry age-related macular degeneration.
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