Roche’s Vabysmo (faricimab) Receives EC’s Approval for Neovascular Age-Related Macular Degeneration and Visual Impairment due to Diabetic Macular Edema
Shots:
- The approval was based on the 4 P-III studies (TENAYA & LUCERNE) in nAMD at 1yr. & (YOSEMITE & RHINE) in DME at ~2yr. evaluating Vabysmo vs aflibercept in 3220 patients
- All studies met their 1EPs i.e., patients treated with Vabysmo administered at q4mos. achieved similar vision gains & anatomical improvements vs aflibercept (q2mos.). The 2EPs of (TENAYA & LUCERNE) and (YOSEMITE & RHINE) studies, (46% & 45% and 52% & 51%) were able to be treated q4mos. in 1yr. and (34% & 33% and 21% & 20%) at q3mos.
- In (YOSEMITE & RHINE) study @2yr., patients achieved q4mos. dosing increased to 60% & 64% while 18% & 14% at q3mos., was well tolerated with a favorable benefit-risk profile, 33% & 21% achieved fewer median no. of inj. for nAMD & DME
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
