A post-hoc analysis didn’t reveal any differences in outcomes by race, macular thickness or baseline visual acuity.
Digging into subgroup analyses of the PULSAR trial didn’t reveal any major differences outcomes, according to Keyvan Koushan, M.D., a retina specialist at the Toronto Retina Institute and a lecturer in the Department of Ophthalmology and Vision Sciences at the University of Toronto.
Data from the phase 3 trial testing 8-mg doses of Eylea (aflibercept) were featured during the Saturday morning session of the American Society of Retina Specialists annual scientific meeting in Seattle.
Koushan said in an interview with Managed Healthcare Executive before to the meeting that his post-hoc subgroup analyses included grouping the 1,000 participants in the three-arm study by visual acuity, macular thickness (as measured by optical coherence tomography), race and other factors. The results showed that the subgroups fared similarly with no major differences to the overall result of the 8-mg doses, given further apart, having the same effect as the 2-mg dose given more frequently.
Koushan said that “there are definitely other chapters to be written” with respect to high-dose Eylea; he noted that the results he is presenting are at the one-year mark and the study is designed for two years, “so we are not done yet.”
But he also said his and the other results for PULSAR are promisingand the side effect profile of the higher doses has been reassuring, even though the volume of injections is higher than the standard volume of injections into the eye and there had been some concern among retinal specialists about intraocular pressure.