Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA regarding the resubmitted BLA for ONS-5010/LYTENAVA.
The CRL cited a lack of substantial evidence of effectiveness as the primary deficiency.
Despite the setback, Outlook Therapeutics remains committed to providing a safe and effective alternative for wet AMD patients.
Regulatory Update
FDA issued a CRL for lack of evidence of effectiveness in ONS-5010 BLA.
Next Steps
Outlook Therapeutics plans to address FDA's issues to potentially gain approval for the product.
European Expansion
LYTENAVA granted Marketing Authorization for wet AMD treatment in the EU and UK, with commercial availability in Germany and the UK.
- The CRL highlights the importance of confirming efficacy for the product in treating wet AMD.
- Outlook Therapeutics aims to collaborate with the FDA to meet the requirements for approval.
Despite the setback with the CRL, Outlook Therapeutics remains resolute in its mission to enhance the standard of care for wet AMD treatment.