Outlook Therapeutics Inc. (NASDAQ: OTLK) submitted a formal dispute resolution request to the U.S. Food and Drug Administration regarding the agency's December 30, 2025 Complete Response Letter for its drug application. The FDA has accepted the request and granted a meeting with the deciding official to be conducted in April 2026.

The dispute concerns ONS-5010/LYTENAVA (bevacizumab-vikg), an ophthalmic formulation of bevacizumab for treating neovascular age-related macular degeneration. The FDA issued a Complete Response Letter in December 2025, which typically indicates the agency requires additional information before approving a drug application.

Following the Complete Response Letter, Outlook Therapeutics engaged with the FDA multiple times, including a formal Type A meeting on March 2, 2026, which led to the submission of the formal dispute resolution request.

"We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

The company's submission includes clinical, functional, and pharmacodynamic data, along with safety findings from its clinical trials. ONS-5010/LYTENAVA demonstrated improvements in visual acuity in the NORSE TWO Phase 3 trial, which met its primary and key secondary endpoints.

If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications. The drug has already received marketing authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency for treating wet age-related macular degeneration.

Outlook Therapeutics will continue working with the FDA throughout the formal dispute resolution process and will provide updates as developments occur.