First-of-its-kind ophthalmic formulation
LYTENAVA is the first and only FDA-approved formulation for intraocular administration.1,2
LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab formulation for the treatment of neovascular (wet) age-related macular degeneration (nAMD).1,2
Stay informed on LYTENAVA »LYTENAVA is the first and only FDA-approved formulation for intraocular administration.1,2
LYTENAVA dosed monthly demonstrated BCVA improvements vs ranibizumab dosed monthly for 3 months then every 3 months (41.7% vs 23.1% gained ≥15 letters; P=0.0052) and a low rate of ocular adverse reactions.1
LYTENAVA is supplied in a sterile, preservative-free, single-dose glass vial and manufactured entirely at US cGMP-compliant facilities to support a consistent formulation with every dose.1,2
LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab formulation for the treatment of neovascular (wet) age-related macular degeneration (nAMD). It is a preservative-free prescription medicine manufactured specifically for intraocular use (for use in the eye).1,2
LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab formulation for the treatment of nAMD (wet AMD), specifically developed for intraocular administration (delivery into the eye).1,2
Yes. LYTENAVA (bevacizumab gamma) was approved by the European Medicines Agency (EMA) and approved by the Medicines and Healthcare products Regulatory Agency in 2024 for the treatment of nAMD (wet AMD). It was launched in Germany and the United Kingdom in 2025, and in Austria in 2026. LYTENAVA is also the first and only FDA-approved ophthalmic bevacizumab formulation for nAMD (wet AMD) in the United States.2,4
LYTENAVA is a recombinant humanized IgG1 monoclonal antibody specific for human vascular endothelial growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss.
The approval was supported by data from NORSE TWO, a pivotal Phase 3 multicenter, randomized, double-masked, controlled trial that evaluated the efficacy and safety of LYTENAVA in patients with nAMD (wet AMD). Patients received either LYTENAVA 1.25 mg by intravitreal injection monthly for 12 months or ranibizumab 0.5 mg monthly for the first 3 months (on Day 0, 30, and 60) and then every 90 days through Month 11.1
In NORSE TWO, 41.7% (45/108) of patients treated with LYTENAVA gained ≥15 letters in best corrected visual acuity (BCVA) from baseline to Month 11, compared with 23.1% (24/104) of patients treated with ranibizumab (P=0.0052).1
Across 5 NORSE trials, The most common adverse reactionss (≥ 1%) reported in patients receiving LYTENAVA were conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%) (small spots or shapes that may appear in vision).1
LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab formulation for the treatment of nAMD (wet AMD). Developed and manufactured specifically for intraocular use (use in the eye), it was approved through a standalone Biologics License Application (BLA) supported by its own clinical, nonclinical, and manufacturing data.1,2
The approved dosage is 1.25 mg (0.05 mL) administered by intravitreal injection (injection into the eye) once monthly (approximately 28 days).1
LYTENAVA is supplied in a sterile, single-dose glass vial manufactured entirely at US cGMP-compliant facilities.1,2
LYTENAVA is administered through intravitreal injection (injection into the eye) by a qualified eye care professional.1
For intravitreal administration (delivery into the eye), a 5-µm sterile filter needle (18-gauge × 1.5-in), a 1-mL syringe and a 30-gauge sterile injection needle are recommended.1
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1. LYTENAVA™ (bevacizumab-vikg) prescribing information. Outlook Therapeutics; 2026. 2. Outlook Therapeutics. Outlook Therapeutics announces resubmission of Biologics License Application to US FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg). Exhibit 99.1 to Current Report on Form 8-K. US Securities and Exchange Commission. Published June 1, 2026. Accessed July 10, 2026. https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/tm2616461d1_ex99-1.htm 3. European Medicines Agency. Lytenava: EPAR – medicine overview. Marketing authorisation issued May 27, 2024. Updated June 29, 2026. Accessed July 15, 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava 4. Outlook Therapeutics. Outlook Therapeutics announces commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK for the treatment of wet AMD. News release. June 2, 2025. Accessed July 15, 2026. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-commercial-launch-lytenavatm/
LYTENAVA (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).
LYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately.
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
The most common adverse reactions (≥1%) reported in patients receiving LYTENAVA were conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of LYTENAVA.
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855).
Please see the full US Prescribing Information for LYTENAVA.