Pegcetacoplan shows increased effects over time in geographic atrophy lesion growth
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Topline 24-month data showed a clinically meaningful reduction in geographic atrophy lesion growth from baseline for intravitreal pegcetacoplan compared with sham in the phase 3 DERBY and OAKS studies, according to Apellis Pharmaceuticals.
In the DERBY study, geographic atrophy (GA) lesion growth was reduced by 19% with monthly pegcetacoplan (P = .0004) and 16% with every-other-month pegcetacoplan (P = .0030). In the OAKS study, GA lesion growth was reduced by 22% with monthly treatment (P < .0001) and 18% with every other-month-treatment (P = .0002).
Additionally, pegcetacoplan compared with sham showed an accelerated effect in the 6-month period of 18 to 24 months vs. the previous 6-month periods, with 36% reduction of GA lesion growth with monthly treatment (P < .0001) and 29% with every-other-month treatment (P = .0002) in the DERBY study and 24% reduction with monthly treatment (P = .0080) and 25% reduction with every-other-month treatment (P = .0007) in the OAKS study.
There was no clinically meaningful difference between pegcetacoplan and sham in key secondary endpoints measuring visual function at 24 months. Pegcetacoplan demonstrated a continued favorable safety profile.
“I am thrilled to see the increased effects over time, which suggest that pegcetacoplan is
preserving more and more photoreceptor cells that are directly responsible for vision,” Eleonora Lad, MD, PhD, lead principal investigator for the OAKS study, said in an Apellis press release. “It is very exciting to finally be on the brink of the first potential GA treatment with pegcetacoplan.”
The Prescription Drug User Fee Act target action date for pegcetacoplan is Nov. 26.
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