PULSAR: Extended dosing intervals for wet AMD maintained at 2 years with aflibercept 8 mg
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Key takeaways:
- At 2 years, 88% of patients treated with aflibercept 8 mg were on a dosing interval of at least 12 weeks.
- Safety of aflibercept 8 mg was consistent with Eylea in previous wet AMD trials.
The majority of patients with wet age-related macular degeneration who received aflibercept 8 mg maintained extended dosing intervals through 2 years in a pivotal trial, according to a press release from Regeneron.
The double-masked, active-controlled PULSAR trial is investigating the noninferiority of aflibercept 8 mg at dosing regimens of 12 weeks (335 patients) and 16 weeks (338 patients) compared with Eylea (aflibercept 2 mg) at a dosing regimen of 8 weeks (336 patients), with all participants receiving three initial monthly doses.
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At the end of 2 years, 88% of patients treated with aflibercept 8 mg were on a dosing interval of at least 12 weeks, with 78% maintaining this dosing interval throughout the 2-year study period compared with 83% who maintained it throughout the first year. Seventy-one percent of patients met the criteria for longer dosing intervals: 47% for intervals of at least 20 weeks and 28% for intervals of 24 weeks.
Additionally, 70% of patients assigned to the dosing regimen of at least 16 weeks maintained this interval throughout the 2-year study period. At the end of 2 years, 78% were eligible for dosing intervals of at least 16 weeks, with 53% eligible for dosing intervals of at least 20 weeks.
The safety of aflibercept 8 mg was consistent with the safety profile of Eylea in previous wet AMD clinical trials, with no reports of retinal vasculitis, occlusive retinitis or endophthalmitis.
Vision gains were sustained through 2 years and remained consistent with the results at 1 year.
“Through 1 and 2 years of treatment, aflibercept 8 mg has repeatedly demonstrated unprecedented durability in maintaining clinically meaningful outcomes with extended dosing regimens for patients with retinal disease,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, said in the release. “With PHOTON and now PULSAR, we are proud to have produced landmark, long-term results that may help to reduce the treatment burden for the millions of people living with wet age-related macular degeneration and diabetic macular edema around the world.”
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