FDA Issues CRL for Bevacizumab Used for Wet AMD

Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLAOutlook Therapeutics plans to work with FDA to address the Agency’s issuesCompany to...

FDA Once Again Turns Down Outlook Therapeutics' Wet AMD Candidate

The FDA issued a complete response letter (CRL) to Outlook Therapeutics for its biologics license application (BLA) resubmission for bevacizumab-vikg, an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD.  In the CRL, the FDA said it could not approve the application in its present form, citing a lack of substantial evidence of effectiveness. The FDA advised that, because ONS-5010 did not meet the primary efficac…

FDA Issues CRL for Bevacizumab Used for Wet AMD

This marks the second complete response letter (CRL) received by Outlook Therapeutics for its treatment targeting wet age-related macular degeneration (AMD).

FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010

FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

FDA again rejects Outlook Therapeutics’ version of Avastin for wet AMD

The FDA has once again shot down Outlook Therapeutics’ attempt to get its version of bevacizumab approved for wet AMD, stipulating it "cannot approve the application in its present form," the company