Outlook Therapeutics, Inc. (OTLK), Friday said it has resubmitted its Biologics License Application (BLA) to the U.S.Food and Drug Administration or FDA for ONS-5010 to treat wet age-related macular degeneration (wet AMD).
A decision from the regulator is expected within six months.
The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT study, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. The FDA had previously issued a Complete Response Letter (CRL) citing several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
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