regulatory
confidence high
sentiment positive
materiality 0.85
Outlook Therapeutics receives EU marketing authorization for LYTENAVA (bevacizumab gamma) for wet AMD
Outlook Therapeutics, Inc.
- 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.