FDA accepts resubmitted biologics license application for bevacizumab-vikg in wet age-related macular degeneration

FDA review could bring the first approved ophthalmic bevacizumab formulation for wet age-related macular degeneration to the USA

The FDA has accepted Outlook Therapeutics’ resubmitted biologics license application for bevacizumab-vikg (LYTENAVA™; Outlook Therapeutics, Inc., Iselin, NJ, USA) for the treatment of neovascular, or wet, age-related macular degeneration (AMD). The application has been classified as a Class 1 review, with a Prescription Drug User Fee Act target action date of July 29, 2026.¹

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Wet AMD is an advanced form of AMD characterized by choroidal neovascularization, vascular leakage, and damage to the macula, which can lead to rapid central vision loss if not treated promptly.² Anti-vascular endothelial growth factor (VEGF) therapy is the established treatment approach for wet AMD, and intravitreal bevacizumab has been widely used off-label in clinical practice.³ However, no ophthalmic formulation of bevacizumab has received FDA approval to date.¹

Outlook Therapeutics announced on June 16, 2026, that the FDA had acknowledged receipt of the resubmission for ONS-5010/LYTENAVA™ for wet AMD. The company stated that bevacizumab-vikg remains investigational in the USA and, if approved, would become the first FDA-approved ophthalmic formulation of bevacizumab.¹

The press release did not include new detailed efficacy or safety data from the clinical development program. Outlook Therapeutics stated that the resubmission represents a further step toward potential FDA approval and that the company has initiated pre-launch activities in anticipation of the pending regulatory decision.¹

Bevacizumab-vikg is described by Outlook Therapeutics as a recombinant humanized monoclonal antibody that binds VEGF and inhibits VEGF-mediated endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.¹ In the EU and UK, LYTENAVA™ is known as bevacizumab gamma and has received marketing authorization for the treatment of wet AMD. Commercial launch has commenced in Germany, Austria, and the UK, although pricing and reimbursement approval is required in some EU member states before the product can be sold.¹

For retina specialists, FDA approval would create a labeled ophthalmic bevacizumab option for wet AMD in the USA, supported by standardized manufacturing and FDA-approved labeling. Until the FDA completes its review, bevacizumab-vikg remains investigational in the USA, and clinical use will depend on the final regulatory decision.

References:

1. 1. Outlook Therapeutics, Inc. (June 16, 2026). Outlook Therapeutics announces FDA acceptance of resubmitted biologics license application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a treatment for wet AMD [Press release]. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-fda-acceptance-resubmitted
   2. Apte RS. Age-related macular degeneration. N Engl J Med. 2021;385:539–47.
   3. Fleckenstein M, Keenan TDL, Guymer RH, et al. Age-related macular degeneration. Nat Rev Dis Primers. 2021;7:31.