LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NORSE EIGHT)

July 24, 2026: Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced the FDA approved LYTENAVA (ONS-5010; bevacizumab-vikg) for treatment of neovascular (wet) age-related macular degeneration (nAMD) in the U.S. The company says this is the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD, providing an eye-specific product (intravitreal use) with FDA-approved labeling and manufacturing/quality oversight. Outlook anticipates 12 years of reference product exclusivity under the BPCIA.

Commercially, Outlook stated it is executing a U.S. launch (reimbursement/patient support and a specialized retina sales organization) and expects LYTENAVA to be available to eligible U.S. patients before year-end.

The release also notes LYTENAVA (as “bevacizumab gamma” in the EU/UK) has received European Commission centralized marketing authorization and MHRA marketing authorization for wet AMD; sales in some EU countries depend on pricing/reimbursement decisions. Safety information highlights risks associated with intravitreal injections (e.g., endophthalmitis/retinal detachment), potential intraocular pressure increases, and potential arterial thromboembolic events; common adverse reactions (≥1%) included conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%).