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: Bayer and Regeneron | Image: Bayer and Regeneron| Press Release
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