Outlook Therapeutics Completes Type A Meeting with FDA on ONS-5010 BLA Resubmission.

Outlook Therapeutics has completed a Type A Meeting with the FDA to discuss a complete response letter regarding the biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet AMD. The company expects to resubmit its BLA before the end of 2025 after reviewing the agency's feedback and meeting minutes.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) has completed a Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet age-related macular degeneration (AMD). The company expects to resubmit its BLA before the end of 2025 after reviewing the agency’s feedback and meeting minutes Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].

During the meeting, Outlook Therapeutics discussed the CRL dated August 27, 2025, with the FDA. The company anticipates addressing the feedback provided and resubmitting the BLA in the fourth quarter of 2025. CEO Bob Jahr stated, "We had a productive discussion with the FDA. Based on our meeting, and pending receipt of the agency’s written minutes, we plan to resubmit the BLA later this year. We remain committed to providing patients, physicians, and payors in the U.S. with a safe and effective ophthalmic bevacizumab for the treatment of wet AMD" Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].

ONS-5010, branded as LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), is an ophthalmic formulation of bevacizumab designed for treating wet AMD. It has received Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. In the United States, ONS-5010 is still in the investigational phase Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].

Bevacizumab-vikg is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity by blocking its interaction with receptors on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].

Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ to optimize the standard of care for bevacizumab in the treatment of retina diseases. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].

The company's forward-looking statements include plans to resubmit the BLA for ONS-5010 and the expected timing thereof, the potential to obtain FDA approval for ONS-5010, and the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD. However, these statements are subject to risks, uncertainties, and factors relating to the company's operations and business environment Outlook Therapeutics Provides Update on Type A Meeting with FDA^[1].