Bayer Submits Application to MHLW for Marketing Authorization of Aflibercept in Japan
- The company has submitted an application to the MHLW seeking approval of aflibercept for nAMD & DME. The submission was based on the P-III trial (PULSAR) in nAMD & P-II/III trial (PHOTON) in DME evaluating aflibercept (8mg with 12 & 16wk. dosing regimens) vs Eylea (2mg, q8w) in 1,164 patients
- Both the trials met their 1EPs & showed a comparable visual acuity with extended treatment intervals of q12w & q16w to Eylea, following initial monthly doses @48wk., patients maintained their treatment interval (79% & 91%) at q12w dosing arm through 48wk.; (77% & 89%) at q16w dosing arm
- The therapy showed a rapid & resilient fluid control to 48wk. The safety results were consistent with prior trials with no cases of endophthalmitis or retinal vasculitis
Ref: Bayer | Image: Bayer
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