Following years of regulatory setbacks that saw multiple rejections, Outlook Therapeutics has secured US Food and Drug Administration (FDA) approval for eye disease drug Lytenava (bevacizumab).
Outlook’s Lytenava is approved for treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. The drug is administered by intravitreal injection.
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Bevacizumab is already a commonly used first-line off-label treatment option for wet AMD, owing to its anti-vascular endothelial growth factor (anti-VEGF) action, which blocks a protein that causes leaky blood vessels. Bevacizumab was originally developed by Roche’s Genentech as an anti-cancer therapy under the brand name Avastin and is normally administered by intravenous injection.
Outlook says that, for the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye. Wet AMD is an eye disorder characterised by the growth of abnormal vessels in the macula. These leak blood or fluid, which leads to a rapid loss of vision.
Outlook’s CEO Bob Jahr commented: “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 that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.”
Outlook stated it is executing the commercial launch for Lytenava, with availability for eligible US patients set to start before the end of 2026.
While Lytenava is already approved in Europe and the UK, FDA approval for the injection means Outlook has its first commercial product in the US. It has been far from a straightforward journey to this milestone. The US biotech was on the receiving end of three complete response letters (CRLs) from the FDA since a first regulatory submission to the agency in 2022. The central underlying qualm from the agency was a lack of substantial evidence of effectiveness, which Outlook contested.
Following the third CRL, Outlook filed a formal dispute resolution request in April 2026. The FDA Office of New Drugs granted the appeal a month later, agreeing that substantial evidence of effectiveness had in fact been met.
With marketing authorisation granted, Outlook joins a competitive wet AMD market. While it has gone through significant shifts in recent years, it is still dominated by anti-VEGF drugs. Bayer and Regeneron’s Eylea (aflibercept) has long dominated the global wet AMD market, netting nearly $8bn in sales in 2025. However, Eylea is undergoing patent expiries, opening the door for Roche’s Vabysmo (faricimab) – also an anti-VEGF medication – to gain market share.
Outlook places the value of the US anti-VEGF retina market alone at approximately $8.5bn. Analysis by GlobalData’s Pharma Intelligence Center forecasts it will rise to $13.8bn in 2033.
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