FDA Accepts Outlook Therapeutics Biologics License Application for ONS-5010 for Wet AMD

Outlook Therapeutics (Nasdaq: OTLK) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for ONS-5010, their ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The FDA designated it as a Class 2 review with a PDUFA goal date of August 27, 2025.

If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity. The resubmission includes efficacy and safety data from the NORSE EIGHT trial, along with additional chemistry, manufacturing, and controls information requested by the FDA.

The company has already secured regulatory approval for this treatment in the European Union and United Kingdom, marking it as the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions.

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