← Back to feed FDA accepts Outlook Therapeutics's resubmitted BLA for LYTENAVA in wet AMD Sponsor Outlook Therapeutics
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Drug LYTENAVA · bevacizumab-vikg
Indication Neovascular (wet) age-related macular degeneration More on Outlook Therapeutics ↗ Google News FDA acknowledged receipt of Outlook Therapeutics's resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for neovascular (wet) age-related macular degeneration. The resubmission is a Class 1 review with a PDUFA target action date of July 29, 2026 — approximately three weeks out. If approved, LYTENAVA would be the first and only ophthalmic formulation of bevacizumab with FDA-approved labelling and standardised manufacturing, replacing the off-label use of oncology-formulation Avastin that currently dominates the wet-AMD anti-VEGF injection market.
Read original at finance.yahoo.com ↗ Background Drug-class context · Wikipedia Neovascular age-related macular degeneration (nAMD or wet AMD) is a leading cause of blindness in adults over 50, driven by pathological choroidal neovascularisation with vascular endothelial growth factor (VEGF)-dependent vascular leakage into the macula. Standard-of-care is monthly-to-bi-monthly intravitreal anti-VEGF injection with aflibercept (Eylea/Eylea HD, Regeneron), ranibizumab (Lucentis, Genentech/Novartis) or faricimab (Vabysmo, Roche). A very large share of U.S. wet-AMD injections use bevacizumab (Avastin, Genentech), an oncology-formulation anti-VEGF that is roughly 40× less expensive than the branded ophthalmic products but is used entirely off-label — compounded from oncology vials by 503A/503B pharmacies with no FDA labelling for intravitreal use, no ophthalmic-specific manufacturing controls, and periodic safety alerts tied to compounding-facility contamination events. ONS-5010 (LYTENAVA, bevacizumab-vikg) is a formulation of bevacizumab specifically manufactured for intravitreal use, packaged in single-use vials with an FDA-standardised label. Outlook Therapeutics's original BLA received a Complete Response Letter in 2023 tied to CMC and third-party manufacturing questions; the resubmitted BLA under FDA acceptance July 29, 2026 PDUFA is the second cycle. LYTENAVA already carries marketing authorisation in the European Union (EMA, 2024) and the United Kingdom (MHRA, 2024) for the same indication. If approved, LYTENAVA would be the first and only bevacizumab formulation with FDA-approved ophthalmic labelling.
Source: Wikipedia · CC BY-SA
Topic ophthalmology
