Regeneron’s Aflibercept Study: A Closer Look at Retinal Vasculitis Incidence

Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.

Regeneron Pharmaceuticals is spearheading a study titled ‘Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry.’ This research aims to estimate the occurrence of retinal vasculitis (RV) in patients receiving aflibercept 2 mg, a treatment used in US clinical practice. The study’s significance lies in its potential to enhance understanding of RV incidence, which could inform future therapeutic strategies and patient management.

The intervention under investigation is aflibercept 2 mg, administered intravitreally. Aflibercept, marketed as Eylea®, is designed to treat various retinal conditions by inhibiting vascular endothelial growth factor (VEGF), thus reducing abnormal blood vessel growth and leakage.

This observational study employs a cohort model with a retrospective time perspective. It utilizes secondary data from the IRIS Registry to identify and confirm RV cases, ensuring a comprehensive analysis of the treatment’s real-world impact.

The study is set to commence on July 1, 2025, with an estimated start date, and was first submitted on December 24, 2024. The most recent update was submitted on June 23, 2025. These dates are crucial as they mark the study’s progression and readiness to begin data collection.

From a market perspective, this study could influence Regeneron’s stock performance by providing insights into the safety profile of aflibercept, potentially affecting investor sentiment. The findings could also impact the competitive landscape, as other companies in the ophthalmology sector may adjust their strategies based on the study’s outcomes.

The study is currently not yet recruiting, with further details available on the ClinicalTrials portal.