Outlook Therapeutics Expects BLA Resubmission Before End of 2025

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

ISELIN, N.J., September 12, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK) has completed a Type A Meeting with the U.S. Food and Drug Administration (FDA) regarding its biologics license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (AMD). The company expects to resubmit its BLA before the end of 2025 following a productive discussion with the FDA and the receipt of the agency’s written minutes Outlook Therapeutics Provides Update on Type A Meeting ...^[1].

The meeting addressed the complete response letter (CRL) issued by the FDA on August 27, 2025, which rejected the company’s initial BLA submission for ONS-5010. The CRL highlighted the need for additional clarity and data to support the effectiveness of the treatment. Outlook Therapeutics, under the leadership of its CEO Bob Jahr, plans to address these deficiencies and resubmit the BLA later this year Outlook Therapeutics plans FDA BLA resubmission for wet AMD treatment^[2].

ONS-5010, also known as LYTENAVA (bevacizumab-vikg in the U.S., bevacizumab gamma in Europe), has already received marketing authorization from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency for wet AMD treatment. The company has commenced commercial launch of the product in Germany and the UK Outlook Therapeutics Provides Update on Type A Meeting ...^[1].

If approved in the United States, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab specifically for retinal indications, including wet AMD. The company’s shares have declined nearly 49% year-to-date, reflecting investor uncertainty around regulatory approvals Outlook Therapeutics plans FDA BLA resubmission for wet AMD treatment^[2].

Outlook Therapeutics is committed to addressing the FDA’s concerns and providing a safe and effective treatment for wet AMD. The company’s recent appointment of Bob Jahr as the new CEO is expected to guide the company through its current challenges and regulatory hurdles Outlook Therapeutics plans FDA BLA resubmission for wet AMD treatment^[2].