It is a bleak view for Outlook Therapeutics’ wet age-related macular degeneration (AMD) treatment plans after the US Food and Drug Administration (FDA) rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate.
Shares in Outlook Therapeutics fell a hefty 80% when the market opened on 30 August. Prior to the FDA’s complete response letter (CRL), a GlobalData consensus estimated Outlook to potentially earn $989m in 2029 if the drug was approved.
GlobalData is the parent company of Pharmaceutical Technology.
Despite ONS-5010 (bevacizumab-vikg) demonstrating positive results in a trial – meeting safety and efficacy endpoints, the agency noted several manufacturing issues and the need for additional confirmatory clinical data.
In a conference call on 30 August, Outlook Therapeutics’ CEO Russell Trenary said: “We are disappointed, and we were certainly not expecting to receive a CRL back from the FDA.”
He added that the company believes the chemistry, manufacturing, and controls (CMC) issues to be manageable, stating “we don’t see any showstoppers”.
During the conference call, company representatives continued to point to the candidate’s strong efficacy showings in trials.
Regarding the need for further clinical evidence as requested by the FDA, Outlook Therapeutics has requested a Type A meeting with the agency. The company will use it to understand the deficiencies in its application and accordingly decide how to proceed with a resubmission for the drug.
During the conference call, the company said it is also in talks with the European Medicines Agency (EMA) regarding approval for the drug in Europe.
Outlook was forecasting the drug, also known as Lytenava, to become the first FDA-approved intravenous (IV) bevacizumab to treat ophthalmic diseases. Currently, the wet AMD market is crowded with Regeneron’s Eylea (aflibercept), Roche’s Lucentis (ranibizumab) and biosimilar versions of Roche’s branded bevacizumab, which is marketed as Avastin. Bevacizumab is not approved for wet AMD, but clinicians have prescribed it off-label to treat the condition. Currently, they use unapproved repackaged IV bevacizumab, which is provided by compounding pharmacies, to treat patients with wet AMD.
Outlook Therapeutics says these products have known risks of contamination and inconsistent potency and availability.
The company had previously resubmitted a BLA last year for the candidate following a voluntary withdrawal to provide extra information requested by the FDA.