Outlook Therapeutics Inc. (NASDAQ:OTLK) surged 17.2% in premarket trading Thursday after announcing that the U.S. Food and Drug Administration has accepted its resubmitted Biologics License Application (BLA) for ONS-5010, an ophthalmic bevacizumab formulation being developed for the treatment of wet age-related macular degeneration (AMD).
The FDA determined that the new filing constitutes a complete Class 1 response to the agency’s August 2023 Complete Response Letter, triggering a shortened 60-day review timeline. The regulator has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2023.
If cleared, ONS-5010—planned to be marketed as LYTENAVA™ (bevacizumab-vikg)—would become the first FDA-approved, retina-ready version of bevacizumab specifically for U.S. wet AMD patients.
“We are pleased that the FDA has accepted our resubmission of the BLA for ONS-5010, marking another important milestone in our effort to bring the first and only FDA-approved ophthalmic formulation of bevacizumab to patients in the United States suffering from wet AMD,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
The company said the revised submission reflects extensive work to address regulators’ concerns and to shore up the application following the agency’s detailed feedback in the August 2023 Complete Response Letter.
Outlook Therapeutics focuses on advancing ophthalmic bevacizumab formulations aimed at improving treatment standards for retinal diseases.