Shares of Outlook Therapeutics rallied 35.3% on Tuesday after the FDA accepted the resubmitted Biologics License Application for its investigational wet AMD treatment ONS-5010, also known as Lytenava. The agency classified the filing as a Class 1 resubmission, setting a decision date of July 29, 2026, and management said the acceptance marks the final stage of the regulatory review process with discussions now focused on product labeling. The acceptance follows a favorable outcome in May 2026 from a Formal Dispute Resolution process in which the FDA concluded that substantial evidence of effectiveness had been established based on the NORSE TWO study together with confirmatory evidence from NORSE EIGHT and additional datasets, effectively overturning the key deficiency cited in three prior complete response letters. If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD, offering standardized manufacturing and FDA-approved labeling. The drug is already approved in the EU and the United Kingdom, where it has been commercially launched in several markets.
OUTLOOK THERAPEUTICS INCFDA accepted resubmitted BLA for wet AMD treatment ONS-5010, setting decision date.
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