Early Clinical Adoption and Treatment Patterns of Avacincaptad Pegol for Geographic Atrophy in the USA: An IRIS® Registry Analysis

The US Food and Drug Administration (FDA) approved avacincaptad pegol (ACP) 2 mg in August 2023 for the treatment of geographic atrophy (GA). With limited data published on real-world use, this study evaluates patient characteristics, treatment patterns, and adverse event (AE) profiles in routine clinical care of patients with GA who received ACP 2 mg during the first year after FDA approval. This noninterventional cohort study of secondary use data from the American Academy of Ophthalmology IRIS ® Registry (Intelligent Research in Sight) followed patients with GA (aged ≥ 50 years at diagnosis) who received their first ACP 2 mg injection (index date) between 1 September 2023 and 31 August 2024, until ACP discontinuation, switching to another GA treatment, loss to follow-up, or end of study. A total of 10,181 patients (13,391 patient-eyes) were included. Mean age was 81.7 years and 65.6% of patients were female. Mean observational follow-up duration was 24.6 weeks (SD: 12.0). The most common ocular comorbidities at baseline were neovascular age-related macular degeneration (nAMD), choroidal neovascularization (CNV)—which overlap clinically and in coding—and cataract. Most (87.1%) patients had bilateral GA; however, 68.5% received ACP treatment in one eye. Patient-eyes received a mean of 3.7 ACP injections during follow-up (mean treatment interval, 7.0 weeks). The discontinuation rate was 8.7%. Overall, 3.6% of patients (2.9% of patient-eyes) experienced a prespecified AE newly recorded within the postinjection window (103 AEs per 10,000 ACP injections), most frequently nAMD and CNV (each < 1% of eyes). This study based on secondary use data provides early insights into ACP 2 mg treatment patterns in patients with GA treated in routine clinical practice within the USA during the first year after approval. Plain Language Summary Geographic atrophy is an advanced form of age-related macular degeneration affecting vision. Over time people with geographic atrophy will lose their vision. The Food and Drug Administration (FDA) in the USA approved avacincaptad pegol (ACP) in August 2023 to treat people with geographic atrophy. In this study, researchers looked at medical records from people with geographic atrophy stored anonymously in the American Academy of Ophthalmology IRIS ® Registry (Intelligent Research in Sight). This study looked at how ACP was used in the real world in US clinics and what health events occurred after treatment. People aged 50 years or older with a confirmed diagnosis of GA were included. They must have had their first treatment with ACP between 1 September 2023 and 21 August 2024. This time period is the first year of ACP approval. A total of 10,181 people with geographic atrophy were included. The results of this study showed that on average, ACP was injected every 7 weeks in the eye and that most people received it in one eye. Few people stopped ACP (8.7%) or switched to another treatment (3.3%). Health events following treatment occurred in 3.6% of people. The results of this study provide early information on how ACP is being used in the real world in US clinical practice.