Outlook Therapeutics Updates on FDA Meeting for ONS-5010/LYTENAVA

Outlook Therapeutics provided an update on their Type A meeting with the FDA regarding their ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA, for retinal indications. The company is advancing the investigational drug for wet age-related macular degeneration, diabetic macular edema, and branch retinal vein occlusion. Bevacizumab-vikg selectively binds to human vascular endothelial growth factor and neutralizes its biologic activity. The drug has undergone three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE.

Outlook Therapeutics, Inc. (OTLK) has completed its Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) received on August 27, 2025, regarding the biologics license application (BLA) for ONS-5010/LYTENAVA, an investigational ophthalmic formulation of bevacizumab. The company plans to resubmit its BLA before the end of 2025, following a thorough review of the FDA's feedback and meeting minutes Outlook Therapeutics Plans BLA Resubmission After FDA ...^[1].

ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab, a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. The drug has undergone three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE, and has received marketing authorization in the European Union and the United Kingdom for the treatment of wet age-related macular degeneration (AMD) Outlook Therapeutics Plans BLA Resubmission After FDA ...^[1].

Outlook Therapeutics anticipates that ONS-5010/LYTENAVA could be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, if approved in the United States. The company remains committed to addressing unmet patient needs in wet AMD treatment despite significant challenges in its financial health Jefferies rates Australia's 4DMedical 'buy' on FDA approval^[2].

The company's CEO, Bob Jahr, described the FDA meeting as productive and reaffirmed the company's commitment to providing a safe and effective ophthalmic bevacizumab treatment option for wet AMD patients in the U.S. Outlook Therapeutics Plans BLA Resubmission After FDA ...^[1].