US Regulator Approves First Purpose-Built Ophthalmic Bevacizumab for Wet AMD

Outlook Therapeutics secures FDA green light for LYTENAVA™, ending two decades of off-label bevacizumab use in retina clinics

The US Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular (wet) age-related macular degeneration, giving American retina specialists their first FDA-sanctioned ophthalmic bevacizumab and closing a regulatory gap that has shadowed anti-VEGF therapy for more than 20 years.

New Jersey-based Outlook Therapeutics (Nasdaq: OTLK) announced the approval on 24 July, describing it as a landmark moment for retina care. Until now, bevacizumab, despite being one of the most widely used anti-VEGF agents in ophthalmology, has only been available to US clinicians as a repackaged, compounded version of a cancer drug never approved for intraocular use. LYTENAVA is the first formulation of the molecule built and approved specifically for intravitreal injection into the eye.

The company said the approval brings retina specialists a therapy backed by dedicated clinical trials, validated manufacturing processes, an approved product label and ongoing FDA oversight, safeguards that off-label, compounded bevacizumab has never carried. Outlook Therapeutics also expects the approval to trigger 12 years of Reference Product Exclusivity under the US Biologics Price Competition and Innovation Act.

"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 Therapeutics chief executive Bob Jahr. He added that clinicians would now have access to a purpose-built formulation offering the manufacturing consistency and regulatory oversight patients deserve.

Firas M. Rahhal, Chairman of Ophthalmology at Good Samaritan Hospital in Los Angeles, welcomed the decision, noting the retina community had waited a long time for an FDA-approved ophthalmic bevacizumab option for wet AMD patients.

A slice of an US$8.5 billion market

Wet AMD remains one of the leading causes of severe vision loss in older adults worldwide, and typically requires years of ongoing intravitreal treatment to preserve sight. Outlook Therapeutics estimates the US anti-VEGF retina market at approximately US$8.5 billion annually, with millions of injections administered each year, a market in which bevacizumab already accounts for the majority of first-line anti-VEGF treatment.

The company says it is now moving into commercial execution mode, building a specialised retina sales organisation, expanding reimbursement pathways, and rolling out patient assistance programs to help physicians integrate LYTENAVA into routine clinical practice. Outlook Therapeutics expects the product to reach eligible US patients before the end of the year.

LYTENAVA already holds marketing authorisation from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency, where it is marketed as bevacizumab gamma and has commenced commercial launch in Germany, Austria and the UK.

Safety profile

According to the US prescribing information, LYTENAVA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to bevacizumab products. Warnings cover the established intravitreal injection risks of endophthalmitis, retinal detachment and transient rises in intraocular pressure, along with a low observed rate of arterial thromboembolic events in clinical trials. The most common adverse reactions reported were conjunctival haemorrhage, eye pain and vitreous floaters.