Regeneron and Bayer’s Promising Phase 3 Study on Aflibercept for Diabetic Macular Edema

Regeneron Pharmaceuticals ((REGN)), Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.

Study Overview: Regeneron Pharmaceuticals and Bayer AG are conducting a Phase 3 clinical study titled ‘Multi-Center, Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of 8 mg Aflibercept in Chinese Participants With Diabetic Macular Edema.’ The study aims to evaluate the efficacy and safety of a higher dose of aflibercept in treating diabetic macular edema (DME) in Chinese patients, potentially reducing the frequency of injections while maintaining safety and efficacy.

Intervention/Treatment: The study tests 8 mg aflibercept, an intravitreal injection, against the standard 2 mg dose. Aflibercept works by inhibiting VEGF, a protein that causes abnormal blood vessel growth and leakage in the eye, aiming to improve visual acuity and reduce treatment burden.

Study Design: This randomized, double-masked, parallel-assignment study involves 322 participants. They are divided into two groups: one receiving 2 mg aflibercept every 8 weeks and the other receiving 8 mg every 16 weeks. The primary goal is to assess visual acuity improvements over 48 weeks.

Study Timeline: The study began on May 29, 2024, with primary completion expected by June 2025. The last update was submitted on June 28, 2025. These dates are crucial for tracking progress and anticipating results that may influence market dynamics.

Market Implications: The study’s outcome could significantly impact Regeneron and Bayer’s stock performance by enhancing their competitive position in the DME treatment market. A successful trial may lead to broader adoption of the higher dose, potentially increasing market share and investor confidence.

The study is ongoing, with further details available on the ClinicalTrials portal.