Apellis Pharmaceuticals has announced long term results from their Phase 3 DERBY and OAKS clinical studies, testing the efficacy and safety of APL-2 (now called intravitreal pegcetacoplan), as a treatment for geographic atrophy (GA). GA is also known as advanced dry age-related macular degeneration.
In an analysis conducted at month 18 of the clinical studies, treatment with both monthly and every-other-month pegcetacoplan reduced GA lesion growth compared to sham injections (no treatment). Pegcetacoplan continued to demonstrate a favorable safety profile in both studies.
Overall, these longer-term results provide further evidence that pegcetacoplan meaningfully slows disease progression and has the potential to preserve vision longer.
Apellis remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 2022. This is one of the first steps towards potentially achieving approval for use. They also look forward to working with global regulatory groups to bring forward the first potential treatment for people living with GA.
Pegcetacoplan is the only targeted C3 therapy in Phase 3 clinical trials for GA, a complement-driven eye disease that causes loss of central vision, affects approximately five million people globally and has no approved treatment.
According to SriniVas Sadda, M.D., President & Chief Scientific Officer of the Doheny Eye Institute and lead investigator, “This study provides exciting evidence to support further exploration of the potential of pegcetacoplan for earlier intervention in the course of GA.”
For current information about all major research for treatment of geographic atrophy, see “A Guide to Research in Dry AMD” on this site.
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SOURCE: Press Release