Outlook Therapeutics Inc (NASDAQ:OTLK) President and CEO Russ Trenary tells Proactive's Stephen Gunnion that the company faces the most significant milestone in its history if the US Food and Drug Administration (FDA) approves its investigational ophthalmic formulation for treating wet age-related macular degeneration (wet AMD).
The FDA has already accepted Outlook's Biologics License Application, with a Prescription Drug User Fee Act goal date of 29 August 2023. If approved, Trenary says ONS-5010 – brand name Lytenava – is expected to receive 12 years of regulatory exclusivity in the US.
It will hit the ground running due to a recent strategic relationship it entered with AmerisourceBergen, he adds.