Extension of PULSAR Shows Durable Improvement From Eylea HD For Wet AMD | ASRS 2025

David T.W. Wong, M.D.

An extension of a pivotal phase 3 trial shows that the functional and anatomic benefits of Eylea HD (aflibercept 8 milligram dose) have staying power in people with neovascular (wet) age-related macular degeneration, according to results presented at the American Society of Retina Specialists annual meeting in Long Beach, California.

At the end of the PULSAR extension trial, with 60 weeks added to the original trial’s 96-week duration, the 208 study participants who switched from a 2-milligram dose of aflibercept to the 8-milligram dose contained in Eylea HD experienced an average improvement of best-corrected visual acuity (BCVA) of 4.6 letters and a decrease in central subfield retinal thickness of 145 micrometers, according to results presented yesterday by David T.W. Wong, M.D., ophthalmologist in chief at St. Michael’s Hospital in Toronto. The 417 study participants who were assigned to the Eylea HD dose from the start of the trial experienced a 3.4-letter gain in BCVA and a slightly smaller, 148-micrometer decrease in central subfield retinal thickness, according to the data presented by Wong.

Lengthening the time between injections is a goal of treatment with anti-vascular endothelial growth factor (VEGF) injections such as Eylea HD. Wong shared data that among the study participants who switched from the 2-milligram dose of aflibercept to the Eylea HD dose, 42% had a last assigned dosing interval of 16 weeks or greater, and 12% had a last assigned dosing interval of 20 weeks. The group treated with the Eylea HD dose from the start of the PULSAR trial ended up with longer dosing intervals: 58% had a last assigned dosing interval of 16 weeks or greater, 40% had a last assigned dosing interval of 20 weeks or greater, and 24% had a dosing interval of 24 weeks or greater.

Wong said the data from the 60-week extension of the PULSAR showed no new safety signals. Seven (3.4%) of the 208 patients who switched from the 2-milligram dose to the Eylea HD dose experienced serious eye-related adverse events. compared with 21 (5%) of the 417 who were assigned the Eylea HD dose from the start of the trial, according to Wong. There were 5 (2.4%) cases of intraocular inflammation in the group that switched doses compared with 8 (1.9%) in the group that was at the 8-milligram dose throughout the 156 weeks of the trial.

The FDA approved Eylea HD for neovascular age-related macular degeneration in 2023 based on positive results from the PULSAR trial at its 48-week mark. The drug was approved for diabetic macular edema and diabetic retinopathy at the same time based on the results of a different phase 3 trial called PHOTON. Regeneron, the company that makes and markets Eylea, the brand name for the 2-milligram dose, and Eylea HD, and researchers continue to plumb the data collected from those trials for evidence of the durability of the response to the anti-VEGF agent and also the safety and effectiveness as dosing intervals are lengthened.

For the company-sponsored PULSAR trial, researchers randomly assigned patients with neovascular age-related macular degeneration who hadn’t been treated to one of three groups: treatment with an 8-milligram injection of aflibercept every 12 weeks, with an 8-milligram injection every 16 weeks, or with a 2-milligram dose every eight weeks, each after three initial “loading” monthly doses. The study participants who completed the main phase of the study were eligible to participate in the 60-week, open-label extension. Patients originally assigned to the regimen of 2-milligram injections every 8 weeks were switched to a regimen of 8-milligram injections every 12 weeks. At week 100, dosing intervals were adjusted in both groups if prespecified disease activity criteria were met, with eight weeks set as the minimum dosing interval and 24 weeks as the maximum.