Outlook: FDA OKs Application for ONS-5010 as a Treatment for Wet AMD

 

• Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a Biologics License Application (BLA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.

https://www.biospace.com/article/releases/outlook-therapeutics-announces-acceptance-of-biologics-license-application-by-u-s-fda-for-ons-5010-as-a-treatment-for-wet-amd/