Bayer Reports EMA's Recommendation for the Approval of Aflibercept to Treat nAMD & Macular Edema
Short:
- The company’s aflibercept has received positive CHMP opinion for aflibercept 8 mg, recommending approval for extended treatment intervals (up to every 4mos., and up to 5mos. in stable cases) in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
- The positive opinion was based on P-III (PULSAR) trial in nAMD and P-II/III (PHOTON) trial in DME evaluating efficacy and safety of aflibercept 8 mg that met their 1EP of non-inferior BCVA changes at 12 and 16wks. dosing regimen vs aflibercept (2mg, Q8W) dosing at wk. 48
- The EC's decision on Bayer's application for the brand name 'Eylea 8mg' (aflibercept 8 mg) is anticipated in the coming months
Ref: Bayer | Image: Bayer
Related News:- Regeneron Presented Two-Year Results from (PHOTON) Trial of Aflibercept for Diabetic Macular Edema at ASRS 2023
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
