FDA Rejects Outlook Therapeutics' Eye Disease Drug, Stock Plummets
The US FDA has declined to approve Outlook Therapeutics' experimental eye disease drug, citing manufacturing issues observed during pre-approval inspections. The drug, ONS-5010, is being developed as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases. Outlook Therapeutics will request a meeting with the FDA to address the issues, while the European Medicines Agency is set to begin its review process for the drug.