ISELIN, N.J. — November 13, 2025 — Leads & Copy — Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (AMD).
The FDA has designated a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025, for ONS-5010, which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for treating wet AMD.
The FDA considers the BLA resubmission a complete, Class 1 response to the action letter issued on August 27, 2025, resulting in a 60-day review period from the resubmission date.
According to Bob Jahr, Chief Executive Officer of Outlook Therapeutics, the acceptance of the BLA resubmission marks a crucial milestone in bringing the first and only FDA-approved ophthalmic formulation of bevacizumab to patients in the United States suffering from wet AMD.
Jahr added that the Outlook Therapeutics team has diligently addressed the agency’s feedback, strengthening the resubmitted BLA and resolving the outstanding issue highlighted in the Complete Response Letter (CRL) from August 2025.
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) has secured a centralized Marketing Authorization from the European Commission in the EU and a Marketing Authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the same indication.
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) selectively binding with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizing VEGF’s biologic activity through steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.
Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance bevacizumab’s standard of care for treating retina diseases.
LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for treating wet AMD, with Outlook Therapeutics having commenced commercial launch in Germany and the UK.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational and, if approved, would be the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Jenene Thomas, Chief Executive Officer, JTC Team, LLC, can be contacted for investor inquiries at 908.824.0775 or OTLK@jtcir.com.
Source: Outlook Therapeutics, Inc.
