Reduction in GA lesion growth continues at 18 months with pegcetacoplan
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Pegcetacoplan intravitreal injections continued to reduce geographic atrophy lesion growth in patients with age-related macular degeneration at 18 months, according to two phase 3 studies.
The positive long-term results of the DERBY and OAKS studies show that the intravitreal drug has the potential to slow disease progression and preserve a patient’s vision for longer, Apellis Pharmaceuticals announced in a press release.
“Geographic atrophy is a tremendously devastating disease that severely impacts vision and leads to, essentially, loss of vision, legal blindness and loss of independence,” Jeffrey S. Heier, MD, principal investigator of the DERBY study, told Healio/OSN. “This is a truly debilitating disease for elderly patients.”
Heier said the main goal of the study was to assess the ability of pegcetacoplan to slow or stop progression of geographic atrophy (GA). Other parameters such as safety were also evaluated.
In the OAKS study, GA lesion growth was reduced by 22% with monthly treatment (P < .0001) and by 16% with treatment every 2 months (P = .0018) compared with pooled sham treatment at 18 months. In the DERBY study, the reductions in GA lesion growth were 13% with monthly treatment (P= .0254) and 12% with treatment every 2 months (P = .0332).
Reduction in GA lesion growth improved with monthly treatment from 13% at 0 to 6 months to 21% at 12 to 18 months. With treatment every 2 months, reduction in lesion growth improved from 12% at 0 to 6 months to 17% at 12 to 18 months.
“What was really good about the 18-month data is that we saw continued benefits in both DERBY and OAKS,” Heier said. “The curves that were seen at year 1 continued over the next 6 months of the study.”
Pegcetacoplan demonstrated a favorable safety profile at 18 months that was consistent with safety at 12 months and longer exposure to intravitreal injections.
Heier said a treatment for GA would be a game changer on the same scale as the first treatments for wet AMD.
“If this is approved, I would envision offering this to many of my patients who have significant geographic atrophy, especially patients who are at risk of vision loss,” Heier said. “It is very encouraging to us as clinicians and to our patients that we appear to be on the verge of a treatment for geographic atrophy. It’s an exciting time.”
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