Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals, in collaboration with Bayer, has recently completed a Phase 4 clinical 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 aimed to assess the blood levels of aflibercept, a drug designed to block the vascular endothelial growth factor (VEGF), in patients with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD).
The intervention being tested is Aflibercept (BAY86-5321, Eylea), administered via 8 mg intravitreal injections in both eyes. This drug is intended to reduce abnormal blood vessel growth and leakage in the eye, which are common issues in DME and nAMD.
The study was interventional, non-randomized, and utilized a parallel assignment model without masking. Its primary purpose was to gather pharmacokinetic data on aflibercept. Participants were divided into three experimental groups, each receiving different dosing schedules of the drug.
The study began on September 8, 2024, and was last updated on October 31, 2025. These dates mark the initiation of participant enrollment and the most recent data submission, respectively, indicating the study’s progression and completion.
This study’s completion could positively influence Regeneron’s stock performance by reinforcing investor confidence in the efficacy and safety of aflibercept, potentially leading to expanded market use. As a leader in the ophthalmology sector, Regeneron’s advancements may also pressure competitors to accelerate their research efforts.
The study is now completed, and further details are available on the ClinicalTrials portal.