Pegcetacoplan safe, effective over 24 months in patients with geographic atrophy
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NEW ORLEANS — Pegcetacoplan slowed lesion growth and was well-tolerated when given monthly or every other month in patients with geographic atrophy secondary to age-related macular degeneration, according to a presenter at Academy ‘23.
In a pooled analysis of the phase 3 OAKS and DERBY trials, patients aged 60 years and older with geographic atrophy (GA) were randomized to intravitreal pegcetacoplan monthly, pegcetacoplan every other month, sham monthly or sham every other month. The primary outcome of interest was change from baseline in GA lesion area by fundus autofluorescence at 24 months.
The researchers found that GA lesion growth was reduced by 21% in the pegcetacoplan monthly group and 17% in the pegcetacoplan every-other-month group compared with sham groups (P < .0001). Pegcetacoplan also was well-tolerated and most treatment-emergent adverse effects were mild or moderate.
“Something that is very striking is that the sham patients continued to progress in a linear fashion,” Jessica Haynes, OD, FAAO, from the Charles Retina Institute in Germantown, Tennessee, said at an academy-sponsored press event. “However, the slopes of the progression continued to decrease over time in those who were treated, and there was a divergent effect, where at every 6-month interval there was a greater effect of the medication.”
Participants who completed the OAKS and DERBY trials were invited to participate in the GALE extension study, in which those who received active dosing continued their treatment, and those from the sham groups switched to active dosing.
“After the first 6 months of GALE, at 30 months, we had a 24% reduction in growth of GA lesion size in the monthly group and a 21% reduction in the every-other-month group,” Haynes said. “And what’s more, that reduction continued to increase the further we went down.”
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Haynes J, et al. Efficacy and safety of pegcetacoplan in patients with geographic atrophy from the phase 3 OAKS and DERBY trials. Presented at: Academy; Oct. 11-14, 2023; New Orleans.
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