Pegcetacoplan for Treatment of Geographic Atrophy Growth

On December 7, 2023, Schachar published a Viewpoint, “Concerning Syfovre Approval for Geographic Atrophy,” online first in JAMA Ophthalmology. Schachar noted that pegcetacoplan (Syfovre) had recently been approved by the US Food and Drug Administration as a treatment to slow the rate of geographic atrophy (GA) growth, but not as a treatment for im proving visual acuity or reducing the risk of visual acuity loss. He cautioned about potential safety and efficacy concerns that might give clinicians pause, and he advised, “While there is a pressing need for an effective, safe treatment for GA, it is important to exercise caution with the inform ation currently available.” Since the submission, revision, and acceptance of this Viewpoint, the primary outcome results of two 24-month, multicenter randomized clinical trials to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with GA were published. In b oth trials, pegcetacoplan slowed GA lesion growth at both the primary outcome end point at 12 months as well as at 24 months, but there were no differences in key secondary visual function end points, including visual acuity outcomes, at 24 months. Serious ocular treatment-emergent adverse events we re reported in 1% to 2% of participants in these trials. This information was not publicly available at the time of acceptance of this Viewpoint.
Source: JAMA Ophthalmology - Category: Opthalmology Source Type: research