Outlook Therapeutics receives a Complete Response Letter from the FDA regarding the ONS-5010 BLA resubmission for wet AMD treatment.
The FDA cited the need for confirmatory evidence of efficacy in the application.
The company remains committed to providing a safe alternative to compounded Avastin for wet AMD patients.
FDA Complete Response Letter
FDA issued a CRL for the resubmitted ONS-5010 BLA due to the need for additional confirmatory evidence of efficacy.
Company Disagreement with FDA Decision
Outlook Therapeutics expressed disagreement with the FDA's decision but reiterated commitment to gaining approval.
European Market Approval
LYTENAVA™ received Marketing Authorization in the EU and UK for wet AMD treatment, expanding commercial opportunities.
- The FDA's request for more evidence indicates a potential delay in gaining approval for ONS-5010/LYTENAVA™ in the U.S.
- Outlook Therapeutics' efforts to explore approval pathways in the U.S. and expand into European markets demonstrate strategic flexibility.
Outlook Therapeutics faces regulatory challenges with the FDA's CRL but remains dedicated to providing a safe and effective treatment for wet AMD patients. The company's success in the European market presents opportunities for growth and market expansion.