Apellis Reports P-III (DERBY) and (OAKS) Studies Results of Pegcetacoplan for Geographic Atrophy
Shots:
- The P-III (DERBY) & (OAKS) studies evaluating pegcetacoplan (IV) vs sham in 621 & 637 patients with GA secondary to AMD showed increased treatment effects over time
- In a pre-specified analysis in both studies @24mos., reduction in GA lesion growth from baseline over sham (19% & 22% monthly); (16% & 18% EOM) while (36% & 24% monthly) & (29% & 25% at EOM) b/w 18-24mos.
- Reduction of GA lesion growth for extrafoveal lesions (28% monthly; 28% EOM) & (34% monthly; 28% EOM) b/w 18-24mos., favorable safety profile, consistent with safety data. The company plans to submit the MAA to the EMA at the end of 2022 while the marketing application in the US is under Priority Review with a PDUFA date on Nov. 26, 2022
Ref: GlobeNewswire | Image: Apellis
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