EX-99.1 2 tm2621316d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD Landmark FDA Approval Is an Important Milestone in Retina Care, Bringing Patients and Physicians an Ophthalmic Bevacizumab Developed Specifically for the Eye Following Years of Rigorous Clinical and Regulatory Evaluation Company Launches Commercial Franchise Positioned to Establish a New Standard as an FDA-Approved Bevacizumab Therapy Across the Approximately $8.5 Billion U.S. Retina Market Anticipated 12 Years of Market Exclusivity Under the Biologics Price Competition and Innovation Act (BPCIA) ISELIN, N.J., July 24, 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 that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. The approval establishes LYTENA…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Outlook Therapeutics, Inc.
OTLKNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On July 24, 2026, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) approved the Company’s biologics license application for ONS-5010/LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab, for the treatment of neovascular (wet) age-related macular degeneration (wet AMD).…
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.