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 (GLOBE NEWSWIRE) -- 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 LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States. For the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye and supported by rigorous clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and ongoing FDA regulatory oversight. Additionally, the Company anticipates that the approval will provide LYTENAVATM with 12 years of Reference Product Exclusivity under the BPCIA.

Outlook Therapeutics believes this FDA approval establishes a new benchmark for ophthalmic bevacizumab and positions LYTENAVA™ to become the new FDA-approved standard for bevacizumab therapy in patients with wet AMD. Bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD, underscoring its important role in retina care.