By: IPP Bureau
Last updated : July 28, 2026 9:03 am
The company plans to commercially launch the product in US market before the end of 2026
Outlook Therapeutics has received US Food and Drug Administration (FDA) approval for Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), also known as wet AMD, marking the company's first commercial product approval in the US after years of regulatory hurdles.
Lytenava is the first FDA-approved ophthalmic formulation of bevacizumab developed specifically for intravitreal injection, offering retina specialists an approved alternative to the widely used off-label bevacizumab formulations originally designed for intravenous cancer treatment.
Bevacizumab, marketed by Genentech as Avastin for oncology indications, has long been used off-label to treat wet AMD because of its anti-vascular endothelial growth factor (anti-VEGF) activity, which inhibits the abnormal blood vessel growth responsible for vision loss.
"Rather than relying on repackaged formulations originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration," said Bob Jahr, CEO of Outlook Therapeutics.
The company plans to commercially launch Lytenava in the US before the end of 2026.
The approval follows a prolonged regulatory journey. Since its initial submission in 2022, Outlook Therapeutics received three Complete Response Letters (CRLs) from the FDA, primarily over concerns regarding evidence of efficacy. After filing a formal dispute resolution request in April 2026, the FDA's Office of New Drugs reversed its earlier position, agreeing that the company had demonstrated substantial evidence of effectiveness.
Lytenava is already approved in Europe and the UK. With the US approval, Outlook enters the competitive anti-VEGF market for wet AMD, currently led by Eylea (aflibercept) from Bayer and Regeneron, while Vabysmo (faricimab)from Roche continues to gain market share.
Outlook estimates the US anti-VEGF retina market at approximately USD 8.5 billion, with industry forecasts projecting it to grow to USD 13.8 billion by 2033.