Outlook Therapeutics says plans to resubmit BLA before end of CY25

Outlook Therapeutics (OTLK) announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration to discuss the complete response letter dated August 27, 2025 regarding the biologics license application resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes. “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,” commented Bob Jahr, CEO of Outlook Therapeutics.