Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

Shots: The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…

ByDipanshu DixitJanuary 1, 2026

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

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…

ByRidhi RastogiNovember 14, 2025

Outlook Therapeutics’ Lytena Gains the CHMP’s Positive Opinion for the Treatment of Wet AMD

Shots: Outlook’s Lytenava has received CHMP’s positive opinion to treat Wet AMD. If approved Lytenava expected to gain 10 yrs of market exclusivity in EU The opinion was supported by 3 wet AMD clinical programs (NORSE ONE, NORSE TWO & NORSE THREE) assessing ONS-5010 along with retrospective bibliographic literature Lytenava, an ophthalmic formulation of bevacizumab,…

ByDipanshu DixitMarch 22, 2024

Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

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