EX-99.1 2 tm2616461d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) ISELIN, N.J., June 1, 2026 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD). As previously announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics License Application reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), therefore additional trials are not required. The FDR decision directed the Division of Ophthalmology and Office of Specialty Medicin…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Outlook Therapeutics, Inc.
OTLKNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On June 1, 2026, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has resubmitted the Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.
Company context
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA is the only ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD.