Shots:
- The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava
- ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with VEGFR-1/VEGFR-2 on endothelial cells, thereby reducing retinal cell proliferation, vascular leakage, & new blood vessel formation
- Lytenava has received approval from the EC & MHRA for the treatment of wet AMD, with commercial launch initiated in Germany & the UK
Ref: Outlook Therapeutics | Image: Outlook Therapeutics | Press Release
Related News:- Outlook Therapeutics’ Lytena Gains the CHMP’s Positive Opinion for the Treatment of Wet AMD
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