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Subgroup Analysis of PULSAR Produces No Surprises | Keyvan Koushan, M.D., ASRS 2023
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.
It Flopped on Primary Endpoint, But Succeeded on Visual Acuity | ASRS 2023
July 31st 2023AXNOO7, an investigational agent for geographic atrophy, did not affect geographic atrophy lesions but showed positive effects of tests of visual acuity. A novel, neuroprotective mechanism of action may be why.
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When a Biosimilar Might Increase Not Decrease Costs | Ravi Parikh, M.D., M.P.H., ASRS 2023
July 30th 2023The approval of an ophthalmic bevacizumab biosimilar might mean the end of low-cost, repackaged Avastin as an anti-VEGF treatment for retinal diseases, with the unintended consequence of adding $457 million to Medicare B spending.
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Endophthalmitis After Anti-VEGF Injections: A Rare But Real Risk | ASRS 2023
July 30th 2023Researchers used the American Academy of Ophthalmology's IRIS database to quantify the risk of endophthalmitis — inflammation of intraocular fluids — after injections with anti-VEGF drugs. They found that post-injection endophthalmitis occurs, on average, once every 3,500 injections.
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Eylea Biosimilar Produces Favorable Results in a Switching Study | ASRS 2023
July 30th 2023Samsung Bioepsis' SB15 was comparable to Eylea (aflibercept) in a 56-week randomized clinical trial that included a rerandomization at 32 weeks. The rerandomization resulted in 111 study volunteers switching from Eylea to the biosimilar for the last part of the study.
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The Long and Short (Interval Switch) of the PULSAR Trial | ASRS 2023
July 29th 2023About 20% of patients in the trial of a high-dose, longer-interval regimen of Eylea (aflibercept )switched to shorter intervals, according to data presented today at the American Society of Retinal Specialists annual scientific meeting, which is being held in Seattle. Researchers didn't find any clues as to why in their baseline characteristics.
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