---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-060517"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2024-05-13T23:59:59+00:00"
generated_at: "2026-06-02T02:23:40.679239+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics submits UK MAA for ONS-5010 (bevacizumab gamma) for wet AMD

## Summary
- Submitted MAA to UK MHRA via International Recognition Procedure, relying on March 2024 positive CHMP opinion.
- ONS-5010 is proposed as the first on-label ophthalmic bevacizumab for wet AMD in the UK.
- Clinical program support from three completed registration trials: NORSE ONE, TWO, and THREE.
- EU decision on CHMP opinion expected within ~67 days; applies to 27 Member States plus Iceland, Norway, Liechtenstein.

## SEC filing metadata
- accession: 0001104659-24-060517
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2024-05-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465924060517/0001104659-24-060517-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465924060517/tm2414311d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-060517
- JSON: https://secwatch.observer/filing/0001104659-24-060517.json
- Plain text: https://secwatch.observer/filing/0001104659-24-060517.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.