Outlook finally claims FDA approval for AMD drug
Outlook Therapeutics' chief executive, Bob Jahr.
After three knockbacks by the FDA, Outlook Therapeutics has finally pushed its therapy for wet age-related macular degeneration (AMD) over the finish line in the US.
The novel formulation of VEGF inhibitor bevacizumab, approved by the FDA as Lytenava, is the first version of the drug approved for use in wet AMD, a chronic, progressive retinal disease that is one of the leading causes of severe vision loss among older adults worldwide.
While Lytenava has been approved in the EU and UK since 2024, with sales yet to gather much momentum, the product's progress in the US has been stalled by no fewer than three complete response letters (CRLs) from the FDA, one in 2023 and two in 2025.
The last of those, claiming a lack of substantial evidence of effectiveness and issued in December, triggered a formal dispute resolution request to the FDA's Office of New Drugs (OND) by the company in April.
The FDA had sought a new clinical trial of Lytenava to provide confirmatory data on efficacy, but the OND subsequently ruled that collective results from Outlook's NORSE TWO and NORSE EIGHT studies, along with supplemental information from other studies, were sufficient to plug any gaps in the dataset.
NORSE EIGHT failed to meet its primary efficacy endpoint, namely non-inferiority with a formulation of ranibizumab, another VEGF inhibitor, although that endpoint was met in NORSE TWO.
Compounded bevacizumab formulations are sometimes used to treat wet AMD, but because the reference product (Roche's Avastin/MabThera) is only indicated for cancer conditions, they can only be used off-label for ophthalmic conditions like wet AMD. Now, with Lytenava, ophthalmologists have an FDA-approved option for patients.
"For more than two decades, bevacizumab has served as one of the most widely utilised anti-VEGF therapies in retina care, despite the absence of an FDA-approved ophthalmic formulation," said Outlook's chief executive, Bob Jahr.
"Lytenava fundamentally changes that landscape," he added. "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."
The new product launches into a wet AMD market that Outlook estimates is worth around $8.5 billion a year in the US, currently dominated by Regeneron's Eylea (aflibercept), Roche's Vabysmo (faricimab), off-label bevacizumab, and ranibizumab, sold as Lucentis by Novartis/Roche and now available as a biosimilar.
The company expects to launch Lytenava in the US before the end of this year, but hasn't yet disclosed pricing information. In the UK, it has a list price of £470 ($626) per 7.5 mg/0.3 ml vial ex VAT, and given a typical treatment course of seven to nine injections a year, that translates to an annual cost of £3,290 to £4,230.
Roche's Susvimo recommended in EU
In other wet AMD regulatory news, Roche's novel refillable implant formulation of ranibizumab – Susvimo – was recommended for approval in the EU for adults with the disorder.
First launched in the US in 2021, Susvimo was withdrawn in 2022 due to manufacturing defects and subsequently re-launched in 2024. Since then, it has also been approved in the US to treat diabetic macular oedema (DME), another leading cause of vision loss and blindness.
