Fluid resolution at week 4 seems to translate into longer dosing intervals at week 96 of the PULSAR trial that assessed Eylea HD in patients with neovascular (wet) age-related macular degeneration.
One of the goals of anti-vascular endothelial growth factor (VEGF) injections as a treatment of neovascular (wet) age-related macular degeneration is to reduce retinal fluid. It is an elusive goal for some patients. The authors of a literature review published recently in Ophthalmology Retina said that their analysis showed that nearly half of all treated patients have persistent retinal fluid and that almost 1 in 5 never attain complete fluid retention. It is also turning out to be a more complicated story than that a drier retina is a healthier one. Some evidence suggests that subretinal fluid may be neutral or even have some benefits for visual acuity.
Results presented today at the American Society of Retina Specialists annual meeting add another episode to the evolving retinal fluid story. They showed that early fluid resolution was associated with longer dosing intervals of Eylea HD, the 8-milligram dose of aflibercept, and one of the most commonly used anti-VEGF agents.
Michael W. Stewart, M.D.
Michael W. Stewart, M.D., professor and chairman of ophthalmology at Mayo Clinic in Jacksonville, Florida, presented a post-hoc analysis of the PULSAR phase 3 trial that led to the FDA approval of Eylea HD as a treatment for neovascular (wet) age-related macular degeneration.
The researchers who conducted the PULSAR assessed fluid resolution at weeks 4, 8 and 12. Stewart presented data showing that 55.9% of the 583 patients who were treated with Eylea HD were fluid-free at week 4, and that proportion slipped slightly as time went on, to 50.8% being fluid-free at weeks 4 and 8 and 48.5% at weeks 4, 8 and 12. Those percentages were lower for the group of 286 study participants who were assigned to the 2-milligram dose of aflibercept, which Regeneron, the drug’s maker, markets as Eylea. The analysis showed that 21% of those assigned to the Eylea HD dose had fluid present at week 4 but were fluid-free at week 8, and 16.8% had fluid present at weeks 4, 8 and 12.
Stewart and his colleague then set out to see how the absence or presence of fluid was associated with the dosing intervals that patients were assigned at the end of the 96-week trial. Generally speaking, a longer dosing interval is viewed as a positive development for patients because it lessens the burden of treatment — fewer injections and appointments—and is an indication that the anti-VEGF drug is working.
Data shared by Stewart showed that 53% of the 326 patients treated with Eylea HD who were fluid-free at week 4 had been assigned a dosing interval of 20 weeks or more. That percentage didn’t appreciably change for those who were fluid-free at weeks 4 and 8 and at weeks 4, 8 and 12. In contrast, 37% of those who had fluid present at week 4 but were fluid-free at week 8 had a dosing interval of 20 weeks or more at the end of the trial. The percentage was the same for the group that had fluid present at weeks 4, 8 and 12.
In the conclusion of the abstract of the presentation, Stewart and his colleagues summed up that rapid fluid resolution in the initial monthly dosing period may be associated with extended dosing intervals in patients with neovascular age-related macular degeneration who received the 8-milligram dose of aflibercept.
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