OTLK news

Outlook Therapeutics received FDA approval for LYTENAVA (bevacizumab-vikg), the first ophthalmic formulation of bevacizumab, targeting a significant portion of the wet AMD market.

Outlook Therapeutics announced FDA acceptance of its resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for wet AMD, with a PDUFA target action date of July 29, 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic formulation of bevaci…

Outlook Therapeutics resubmitted its Biologics License Application for ONS-5010/LYTENAVA to the FDA after successfully appealing a Complete Response Letter, with a Class 1 review designation and expected decision within 60 days. If approved, the product would be the first FDA-approved ophthalmic for…

The FDA's Office of New Drugs determined that substantial evidence supports the effectiveness of ONS-5010/LYTENAVA for neovascular age-related macular degeneration following the formal dispute resolution process. Outlook plans to resubmit the biologics license application in June 2026 with an expect…