Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting an observational study titled Drug Utilization Study for Eylea 40 mg/mL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK. The study aims to collect data on the use of aflibercept (Eylea) administered via a pediatric dosing device in preterm infants with retinopathy of prematurity (ROP) in the UK. This study is significant as it seeks to determine the prevalence of this treatment method and assess its long-term safety for this vulnerable population.
Intervention/Treatment: The study focuses on the drug aflibercept (Eylea), a solution for injection designed to block a protein that causes abnormal blood vessel growth in the retina. It is administered using a prefilled syringe and a pediatric dosing device to ensure safe and accurate dosing for preterm infants with ROP.
Study Design: This is an observational cohort study with a cross-sectional time perspective. It does not involve any allocation or intervention model as it relies on existing data from the National Neonatal Research Database. The primary purpose is to gather data on the usage and characteristics of infants treated with aflibercept using the pediatric dosing device.
Study Timeline: The study began on March 5, 2024, and is expected to have its primary completion by March 2025, with data collection potentially extending to April 2027 if necessary. The last update was submitted on July 7, 2025. These dates are crucial for tracking the study’s progress and ensuring timely data collection.
Market Implications: This study could influence Bayer’s stock performance by potentially expanding the market for Eylea if the findings support its safety and efficacy in preterm infants. Positive results may boost investor confidence and position Bayer favorably against competitors in the pediatric ophthalmology market. Investors should monitor the study’s outcomes, as they could have significant implications for Bayer’s market strategy and financial performance.
The study is ongoing, and further details are available on the ClinicalTrials portal.