(RTTNews) - Outlook Therapeutics, Inc. (OTLK) announced that it recently held a Type A meeting with the U.S. FDA to discuss the Complete Response Letter (CRL) issued in December 2025 for its Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg).
The FDA highlighted the need for additional confirmatory evidence of effectiveness before the therapy can move forward toward approval. Outlook said it remains committed to working closely with the agency to align on the data requirements and identify the most efficient regulatory pathway.
ONS-5010/LYTENAVA has already demonstrated statistically significant improvements in vision in the NORSE TWO Phase 3 trial, with supportive evidence from the NORSE EIGHT study. The drug candidate also showed a favorable safety profile, with no concerns raised by the FDA.
If approved, ONS-5010 would become the first FDA-approved ophthalmic formulation of bevacizumab for retinal degeneration (AMD), supported by standardized manufacturing and FDA-approved labelling. The product candidate is supported by a fully domestic, end-to-end U.S. manufacturing supply chain.
LYTENAVA received European Commission marketing authorization for the treatment of wet AMD in May 2024. This decision automatically applied across all 27 EU Member States and, within 30 days, extended to Iceland, Norway, and Liechtenstein. The drug was subsequently launched in Germany and the UK in June 2025, and in Austria in January 2026.
Unit sales more than doubled last quarter; however, reported revenue came in negative at $(1.2) million, primarily due to short-dated product returns from its UK distributors tied to initial launch batches. Outlook emphasized that this was a one-time adjustment and expects demand to continue rising as launches expand to Ireland, the Netherlands, and other major EU markets.
OTLK has traded between $0.38 and $3.39 over the past year. The stock closed yesterday's trading at $0.43, down 1.53%. In afterhours trading, it fell a further 0.81% to $0.42.
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