- Outlook Therapeutics ( NASDAQ: OTLK ) on Friday said the U.S. FDA had accepted its biologics license application (BLA) for its eye diseases treatment ONS-5010 (Lytenava).
- The FDA accepted OTLK's BLA submission for ONS-5010 to treat wet age-related macular degeneration, the company said in a statement .
- The drug regulator is set to decide on the BLA by Aug. 29, 2023, or the so-called Prescription Drug User Fee Act date.
- In preparation of ONS-5010's anticipated approval and subsequent launch, OTLK last month tied up with drug distributor AmerisourceBergen ( ABC ).
- OTLK said if ONS-5010 was approved, it is expected to get 12 years of regulatory exclusivity in the U.S.
- Outlook Therapeutics ( OTLK ) stock -4.6% to $1.26 in premarket trading.
For further details see:
FDA accepts Outlook Therapeutics' biologics license application for wet AMD drug