A December 2023 JAMA Ophthalmology Viewpoint piece about Syfovre side effects was reported on in a December 7, 2023, Managed Healthcare Executive article, “Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint”:
An independent panel of retinal specialists and statisticians should assess the clinical trial data for Syfovre (pegcetacoplan injection) and provide an unbiased evaluation of the drug in light of the lack of peer-review publication and a complete FDA review, argues Ira Schachar, M.D., M.Sc., the author of an opinion piece published today in JAMA Ophthalmology.
Schachar also suggests that widespread use of Syfovre should wait until there is a complete FDA scientific analysis of the drug or a peer-reviewed publication of the study results. He says the data released by Apellis Pharmaceuticals raises methodological questions and he questions whether “repeated measures and missing data have been appropriately handled.” Schachar, who was an assistant professor at Stanford prior to joining the North Bay group, says in the one-page viewpoint piece that questions about the Syfovre statistics are “particularly important” because of the high dropout rates from two important, phase 3 trials for the drug called OAKS and DERBY.
This Viewpoint piece about Syfovre side effects, “Concerning Syfovre Approval for Geographic Atrophy”, was published December 7, 2023, online by JAMA Ophthalmology.
The results of the clinical trials OAKS and DERBY were reported in this medical journal article, “Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials”, published October 21, 2023, by The Lancet.
In the Interpretation part of the Abstract for this Lancet medical journal article, lead author Jeffrey S. Heier, M.D., of Ophthalmic Consultant of Boston, and his colleagues stated:
[Syfovre (pegcetacoplan)], the first treatment approved by the US Food and Drug Administration for geographic atrophy, slowed geographic atrophy lesion growth with an acceptable safety profile.
The OAKS and DERBY trials were funded by Apellis Pharmaceuticals. Whether those two phase 3 trials adequately addressed Syfovre side effects seems to be the issue raised by Dr. Schachar in his December 2023 Viewpoint piece.[Read article in full at original source]
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