Regeneron’s High-Dose Aflibercept Trial in China Nears a Key Inflection Point for Eye-Care Growth

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

Regeneron (REGN) and Bayer have completed a Phase 3 eye 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 goal is to see if a higher dose of aflibercept can keep vision stable with fewer injections, which matters for treatment burden and real-world use.

The study tests aflibercept injections into the eye for diabetic macular edema, a diabetes-related cause of vision loss. It compares the already approved 2 mg aflibercept dose with an 8 mg high dose aimed at stretching dosing intervals while keeping safety and vision outcomes similar.

Participants were randomly split into two groups and followed for about 63 weeks. One group received 2 mg aflibercept every 8 weeks after five monthly doses, while the other received 8 mg every 16 weeks after three monthly doses, and neither patients nor doctors knew who got which dose.

The study is interventional and focused on treatment rather than diagnosis or prevention. The main outcome is change in best corrected visual acuity at 48 weeks, which is a simple measure of how well patients can see with glasses, compared between the high-dose and standard-dose groups.

The trial was first submitted on 15 May 2024, marking the start of public disclosure for this program in China. The latest update on 30 Mar 2026 confirms the study status as completed, while the absence of posted results suggests data are still being processed or prepared for publication and regulatory review.

Primary completion is tied to the 48-week vision data that drive the main comparison between doses. Estimated full completion follows after all 63-week visits are done, when safety follow-up is finished and the data set is ready for full analysis and potential inclusion in regulatory filings.

For investors, a positive high-dose result in Chinese patients could support broader global uptake of 8 mg aflibercept and extend the Eylea franchise for Bayer and Regeneron. It may help defend share against rivals in retinal disease, such as Roche and Novartis, where longer-acting eye drugs are a key selling point.

Stronger, longer-acting data could improve pricing power and support steady revenue even as competition grows and biosimilars loom. Conversely, any safety or efficacy concerns could pressure sentiment on REGN, as the market is watching whether high-dose aflibercept can anchor long-term growth in eye care.

While detailed results are not yet posted, the completion and recent update signal that a key data catalyst is near for REGN and Bayer in diabetic eye disease. The study is now completed and updated, with further details available on the ClinicalTrials portal.

To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.