ISELIN, N.J., July 24, 2026
Outlook Therapeutics has achieved a major regulatory milestone after the U.S. Food and Drug Administration (FDA) approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. The approval makes LYTENAVA™ the first and only FDA-approved ophthalmic formulation of bevacizumab specifically developed for intravitreal use in the eye, ending decades of reliance on repackaged intravenous bevacizumab for retinal disorders. Backed by extensive clinical studies, validated manufacturing processes, and FDA-reviewed quality standards, the therapy introduces a purpose-built treatment option for retina specialists and patients. Outlook Therapeutics also expects 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA), strengthening the product’s long-term commercial position in the U.S. market. The company believes the approval establishes a new benchmark for ophthalmic bevacizumab therapies and represents an important advancement in the treatment landscape for patients living with wet AMD.
FDA Approval Brings a Purpose-Built Bevacizumab for Retina Care
LYTENAVA™ was specifically engineered for ophthalmic use, providing physicians with an FDA-approved alternative to compounded or repackaged bevacizumab formulations originally designed for intravenous cancer treatment. According to Outlook Therapeutics, the approval ensures healthcare professionals have access to a therapy supported by rigorous clinical evidence, consistent manufacturing quality, approved product labeling, and ongoing regulatory oversight. Company Chief Executive Officer Bob Jahr described the approval as a defining moment for both the organization and the retina community, emphasizing that patients now have access to an ophthalmic bevacizumab developed exclusively for the eye. Ophthalmology experts also welcomed the decision, noting that retina specialists have awaited an FDA-approved ophthalmic bevacizumab for many years. Wet AMD remains one of the leading causes of severe vision loss among older adults worldwide, often requiring repeated long-term anti-VEGF treatment to preserve eyesight, making product quality and manufacturing consistency particularly important throughout therapy.
Commercial Launch Targets the $8.5 Billion U.S. Retina Market
Following the FDA approval, Outlook Therapeutics has begun executing its commercial launch strategy aimed at expanding patient access across the United States. The company plans to strengthen reimbursement support programs, establish comprehensive patient assistance services, and build a specialized retina-focused commercial organization to support physicians nationwide. LYTENAVA™ enters an estimated $8.5 billion U.S. anti-VEGF retina market, where millions of intravitreal injections are administered annually. Outlook Therapeutics intends to position the product as the trusted FDA-approved bevacizumab option for retina specialists treating wet AMD patients. The company expects LYTENAVA™ to become available to eligible U.S. patients before the end of the year while continuing efforts to integrate the therapy into routine clinical practice through broad reimbursement and access initiatives. Management believes the approval creates a significant opportunity to improve patient care while establishing a leading commercial franchise in retinal disease treatment.
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Global Regulatory Success Strengthens Outlook Therapeutics’ Growth Strategy
Beyond the United States, LYTENAVA™ has already secured Marketing Authorization from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for treating wet AMD, although reimbursement approvals remain necessary in certain European markets before commercialization. The therapy is a recombinant humanized IgG1 monoclonal antibody that targets vascular endothelial growth factor-A (VEGF-A), blocking abnormal blood vessel growth and vascular leakage that contribute to progressive vision loss in wet AMD. The FDA-approved labeling includes important safety information, with the most commonly reported adverse reactions including conjunctival hemorrhage, eye pain, and vitreous floaters, while highlighting monitoring requirements for intraocular pressure and the risk of ocular infections following intravitreal injection. With regulatory approvals now spanning the United States, European Union, and United Kingdom, Outlook Therapeutics is well positioned to expand its global retina franchise while delivering the first FDA-approved ophthalmic bevacizumab specifically designed to improve treatment quality, regulatory confidence, and long-term patient outcomes in wet age-related macular degeneration..
Source: Outlook Therapeutics press release
