Outlook Therapeutics wins FDA approval for Lytenava in wet AMD

Outlook Therapeutics, Inc. announced on July 24, 2026 that the U.S. Food and Drug Administration approved the company's biologics license application for ONS-5010/LYTENAVA (bevacizumab-vikg), an ophthalmic formulation of bevacizumab, for the treatment of neovascular (wet) age-related macular degeneration.¹ The company said the approval establishes LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.¹

The company said it anticipates that the approval will provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA.¹

On the safety profile, the filing states that the most common adverse reaction (≥1%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%).¹ The prescribing information also warns that intravitreal injections have been associated with endophthalmitis and retinal detachments, and proper aseptic injection technique must always be used when administering LYTENAVA.¹ It further notes that although there was a low rate of arterial thromboembolic events observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death.¹

On commercialization, Outlook Therapeutics said it expects to make LYTENAVA available to eligible patients in the United States before year-end.¹ The company noted that outside the U.S., LYTENAVA is also the subject of a centralized Marketing Authorization granted by the European Commission in the EU and a Marketing Authorization granted by the MHRA in the UK, though in certain EU member states it must receive pricing and reimbursement approval before it can be sold.¹ The company said it has already commenced commercial launch of LYTENAVA (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD.¹