The U.S. FDA has issued a CRL for Outlook Therapeutics' BLA for its investigational eye injection under development to treat wet age-related macular degeneration (AMD), setting back the NJ-based company's plans of bringing the first ophthalmic formulation of bevacizumab to market.
In a release shared by the company, Outlook said that while the FDA acknowledged that the company's pivotal trial met its safety and efficacy endpoints, the agency could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections, and a "lack of substantial evidence."
This is not the first obstacle Outlook has faced for its treatment, ONS-5010 (branded Lytenava), which is an ophthalmic formulation of Roche's blockbuster cancer drug, Avastin. Back in May of 2022, Outlook voluntarily withdrew its BLA for the treatment after the FDA had requested additional information.
Confident it had the information the agency was looking for, Outlook resubmitted the BLA last August and later that fall was granted a PDUFA date of August 29, 2023.
According to Outlook, the drug fills an important gap in the treatment of retinal diseases. Currently, clinicians who want to treat retinal patients with bevacizumab have to use unapproved repackaged IV bevacizumab provided by compounding pharmacies —which comes with higher risks of contamination and inconsistent potency.
Outlooks says it will now request a formal meeting with the agency to "further understand the BLA deficiencies and how best to resolve them."
