FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

Bottle of Pills and a FDA APPROVED rubber stamp

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its 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).  There are no FDA-approved ophthalmic formulations of bevacizumab currently available and therefore, according to Outlook, “clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.”

The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023.