Bayer and Regeneron Receive the EC’s Approval for Eylea (aflibercept, 8mg) for the Treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
Shots:
- The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changes
- Both the studies met their 1EP of non-inferior BCVA changes in patients receiving 8mg of Eylea for 12-16wks. dosing regimen vs those receiving 2mg for fixed 8wks. treatment interval at wk.48. Moreover, the safety profiles of the study were consistent with the previous studies of Eylea (2mg)
- Earlier in Aug 2023, the US FDA approved aflibercept (8mg) by the name Eylea HD for nAMD & DME while more applications for approval have been submitted by Bayer to other regulatory bodies. Eylea (8mg) is jointly being developed by Bayer & Regeneron
Ref: Regeneron | Image: Regeneron
Related Post:- Regeneron Reports Two-Year (PULSAR) Trial Results of Eylea HD (aflibercept) for Wet Age-Related Macular Degeneration
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
