The USFDA has approved the pegcetacoplan injection for treating geographic atrophy (GA), a complex disease and a leading cause of blindness secondary to age-related macular degeneration (AMD). This is the first and only approved FDA treatment for GA that affects more than five million people globally. Its approval is considered to be an important event of this decade in the field of retinal ophthalmology.
Clinical Trials The approval is based on significant results obtained from a broad and representative population of patients from 24-month phase 2, OAKS, and DERBY studies. In both studies, monthly and every other month administration of pegcetacoplan reduced the GA lesion growth rate at 24 months compared to sham. OAKS: 22% monthly; 18% every other month DERBY: 18% monthly; 17% every other month The rate of GA lesion growth was found to be reduced along with increased treatment…
