Shots:
- Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other markets
- In the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with improved visual acuity vs Eylea 2mg (Q4W); ~90% maintained extended 8wk. dosing intervals till 36wks., & ~70% (3 initial monthly dosing) reached 12wk. interval. Fluid reduction was comparable with Eylea 2mg
- In Feb 2025, Bayer submitted an MAA to the EMA to extend Eylea 8mg dosing intervals to up to 6mos. for nAMD & DME, supported by data from the PULSAR & PHOTON trial, respectively
Ref: Bayer | Image: Bayer
Related News:- Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
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