---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-065609"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2024-05-28T23:59:59+00:00"
generated_at: "2026-06-01T08:05:57.283198+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics receives EU marketing authorization for LYTENAVA (bevacizumab gamma) for wet AMD

## Summary
- European Commission granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for wet AMD in the EU.
- LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in the EU.
- Approval based on three completed registration trials (NORSE ONE, TWO, THREE) and supporting data.
- Marketing authorization applies automatically to all 27 EU member states plus Iceland, Norway, Liechtenstein.
- Outlook granted an initial 10 years of market exclusivity in the EU for LYTENAVA.

## SEC filing metadata
- accession: 0001104659-24-065609
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2024-05-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465924065609/0001104659-24-065609-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465924065609/tm2415688d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-065609
- JSON: https://secwatch.observer/filing/0001104659-24-065609.json
- Plain text: https://secwatch.observer/filing/0001104659-24-065609.txt

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