Results at 96 weeks were similar to those at 48 weeks. The FDA approved the 8-mg formulation of Eylea (aflibercept) in August 2023.
Treating patients with wet age-related macular degeneration with higher but less frequent doses of Eylea (aflibercept) for two years was just as safe and effective as treating them with lower but more frequent doses, according to results presented at the annual meeting of American Academy of Ophthalmology, which is being held in San Francisco.
The findings from 96-weeks of the PULSAR trial presented by Jean-François Korobelnik, M.D., Ph.D., a professor of ophthalmology at the University Hospital of Bordeaux in France, weren’t surprising. They are similar to previously reported findings at the 48-week mark, and the FDA approved the higher, 8-mg formulation of Eylea, called Eylea HD, in August 2023 as a treatment for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy (DR). The FDA approved the original 2-mg formulation in 2011.
A large proportion of the participants in the PULSAR ended up switching to even longer intervals between treatments during the second year of the study, according to data presented by Korobelnik. Almost one-third (31%) of the 292 patients randomized to be treated every 16 weeks with the 8-mg formulation had switched to being treated every 24 weeks and one-quarter (25%) of 291 randomized to treatment every 12 weeks had done so, Korobelnik reported.
The study volunteers were eligible for longer interval dosing if they had less than a 5-letter loss in best corrected visual acuity (BCVA), no fluid at the center of the macula and no new foveal hemorrhage or neovascularization.
Data shared by Korobelnik significant differences in side effects between the patients randomized for treatment with the 2-mg formulation every 8 weeks and those randomized to the less frequent, 8-mg doses. In fact, intraocular inflammation was more common in the 2-mg group than it was in the group that received 8-mg doses every 12 and 16 weeks (2.1% vs. 1.8% vs. 0.9%).According to Korobelnik, there were no cases of endophthalmitis, ischemic optic neuropathy, occlusive retinitis, or retinal vasculitis among patients in the 8-mg arms of PULSAR.