Outlook Therapeutics (NASDAQ:OTLK) submitted an application to the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet age-related macular degeneration (wet AMD).
The company said ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for wet AMD, a chronic eye disorder that causes blurred vision or a blind spot in the visual field.
The biologics license application (BLA) for ONS-5010 is backed by data from the clinical trials: NORSE ONE, NORSE TWO and NORSE THREE.
The company added that in anticipation of potential FDA marketing approval in late 2022 or early 2023, it has begun commercial launch planning, including partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product.