Regeneron Pharmaceuticals ((REGN)), Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG and Regeneron Pharmaceuticals are conducting a Phase 4 study titled An Open-label, Non-randomized, Multi-center, Phase 4 Pharmacokinetic Study to Evaluate the Systemic Exposure After Bilateral Intravitreal Administration of High Dose (8 mg) Aflibercept in Adults With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration. The study aims to assess the blood levels of aflibercept, a drug used to treat eye disorders like diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD), after high-dose administration in both eyes. These conditions are significant causes of vision loss in adults, making this research crucial for improving treatment options.
Intervention/Treatment: The intervention being tested is Aflibercept (BAY86-5321, Eylea), administered as an 8 mg intravitreal injection in both eyes. Aflibercept works by blocking a protein that causes abnormal blood vessel growth and leakage in the eye.
Study Design: This is an open-label, non-randomized study with a parallel intervention model. There is no masking involved, and the primary purpose is to gather pharmacokinetic data. Participants are divided into three experimental groups, each receiving different dosing schedules of the same treatment.
Study Timeline: The study began on September 2, 2024, with the last update submitted on June 28, 2025. These dates are crucial as they mark the progress and ongoing nature of the study, which is currently active but not recruiting new participants.
Market Implications: The successful completion and positive results of this study could enhance investor confidence in Bayer AG and Regeneron Pharmaceuticals, potentially boosting their stock performance. As these companies are at the forefront of developing treatments for eye disorders, advancements in this study could also impact their competitive positioning in the pharmaceutical industry.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.